28500 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 15, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–9737 Filed 5–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0226] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

017 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 017’’ (Recognition List 

Number: 017), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit written or electronic 

comments concerning this document at 

any time. See section VII of this 

document for the effective date of the 

recognition of standards announced in 

this document. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 017’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health (HFZ–220), Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 240–276–3151. Submit 

written comments concerning this 

document, or recommendations for 

additional standards for recognition, to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). Submit 

electronic comments by e-mail: 

standards@cdrh.fda.gov. This document 

may also be accessed on FDA’s Internet 

site at http://www.accessdata.fda.gov/ 

scripts/cdrh/cfdocs/cfTopic/ 

cdrhnew.cfm. See section VI of this 

document for electronic access to the 

searchable database for the current list 

of FDA recognized consensus standards, 

including Recognition List Number: 017 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health (HFZ–84), Food and 

Drug Administration, 2098 Gaither 

Road, Rockville, MD 20850, 240–276–

0533. 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360d). Amended section 514 

allows FDA to recognize consensus 

standards developed by international 

and national organizations for use in 

satisfying portions of device premarket 

review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards.’’ The notice described how 

FDA would implement its standard 

recognition program and provided the 

initial list of recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, are identified in 

table 1 of this document. 

TABLE 1. 

Federal Register Cite 

October 16, 1998 (63 FR 55617) 

July 12, 1999 (64 FR 37546) 

November 15, 2000 (65 FR 69022) 

May 7, 2001 (66 FR 23032) 

January 14, 2002 (67 FR 1774) 

October 2, 2002 (67 FR 61893) 

April 28, 2003 (68 FR 22391) 

March 8, 2004 (69 FR 10712) 

TABLE 1.—Continued 

Federal Register Cite 

June 18, 2004 (69 FR 34176) 

October 4, 2004 (69 FR 59240) 

May 27, 2005 (70 FR 30756) 

November 8, 2005 (70 FR 67713) 

March 31, 2006 (71 FR 16313) 

June 23, 2006 (71 FR 36121) 

November 3, 2006 (71 FR 64718) 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

agency maintains ‘‘hypertext markup 

language (HTML)’’ and ‘‘portable 

document format (PDF)’’ versions of the 

list of ‘‘FDA Recognized Consensus 

Standards.’’ Both versions are publicly 

accessible at the agency’s Internet site. 

See section VI of this document for 

electronic access information. Interested 

persons should review the 

supplementary information sheet for the 

standard to understand fully the extent 

to which FDA recognizes the standard. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 017 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the agency 

will recognize for use in satisfying 

premarket reviews and other 

requirements for devices. FDA will 

incorporate these modifications in the 

list of FDA Recognized Consensus 

Standards in the agency’s searchable 

database. FDA will use the term 

‘‘Recognition List Number: 017 to 

identify these current modifications. 

In Table 2 of this document, FDA 

describes the following modifications: 

(1) The withdrawal of standards and 

their replacement by others, (2) the 

correction of errors made by FDA in 

listing previously recognized standards, 

and (3) the changes to the 

supplementary information sheets of 

recognized standards that describe 

revisions to the applicability of the 

standards. 

In section III of this document, FDA 

lists modifications the agency is making 

that involve the initial addition of 

standards not previously recognized by 

FDA. 


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TABLE 2. 

Old Item 

No. Standard Change Replacement Item No. 

A. Anesthesia 

19 ISO 8382:1988: Resuscitators Intended for Use With Humans Withdrawn 71 

48 ASTM F1246–91(2005): Standard Specification for Electrically Powered 

Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator Circuits 

Withdrawn and replaced with 

newer version 

70 

B. Biocompatibility 

57 ASTM F895–84(2006): Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity Withdrawn and replaced with 

newer version 

115 

72 ASTM F1439–03: Standard Guide for Performance of Lifetime Bioassay 

for the Tumorigenic Potential of Implant Materials 

Withdrawn and replaced with 

newer version 

116 

86 AAMI/ANSI/ISO 10993–10:2002(E): Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization Withdrawn—duplicate 87 

87 AAMI/ANSI/ISO 10993–10:2002: Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity Title 

99 ASTM F1904–98(2003): Standard Practice for Testing the Biological Responses to Particles In Vivo Title 

C. Dental/Ear, Nose, and Throat (ENT) 

60 ANSI/ADA Specification No. 96:2000: Dental Water-Based Cements Withdrawn and replaced with 

newer version 

143 

72 ISO 6877–2006: Dentistry—Root-canal Obturating Points Withdrawn and replaced with 

newer version 

137 

85 ANSI/ADA Specification No. 15:2000, Synthetic Polymer Teeth Withdrawn and replaced with 

newer version 

138 

91 ANSI/ADA Specification No. 80:2001, Dental Materials—Determination of 

Color Stability 

Title 

114 ANSI/ADA Specification No. 48:2004, Visible Light Curing Units Withdrawn and replaced with 

newer version 

139 

D. General 

2 IEC 60601–1, Medical Electrical Equipment—Part 1:General Requirements for Safety Contact Person 

11 ISO 2859/1995, Sampling Procedures and Tables for Inspection By Attributes Contact Person 

12 ISO 10012/1993, Quality Assurance Requirements for Measuring Equipment Part 1: Metrological Confirmation System for Measuring Equipment Contact Person 

14 ANSI Z1.4/1993, Inspection by Attributes Contact Person 

15 ANSI Z1.9/1993, Inspection by Variables Contact Person 

18 ASTM D–4332/1991, Standard Practice for Conditioning Containers, 

Packages, or Packaging Components for Testing 

Contact Person 

19 ASTM E–876/1995, Standard Practice for Use of Statistics in the Evaluation of Spectrometric Data Contact Person 

20 ASTM F–1140/1988, Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications Contact Person 

27 IEC 60601–1–1:2000, Medical Electrical Equipment—Part 1: General Requirement for Safety; Safety Requirements for Medical Electrical Systems Contact Person 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

28 IEC 60601–1–2, (Second Edition, 2001), Medical Electrical Equipment—

Part 1–2: General Requirements for Safety; Electromagnetic Compatibility—Requirements and Tests 

Extent of Recognition 

29 AAMI/ANSI HE74–2001, Human Factors Design Process for Medical Devices Contact Person 

31 ISO 15223, Medical Devices—Symbols to be Used With Medical Device 

Labels, Labeling and Information to be Supplied 

Contact Person 

32 EN 980:1996+1:1999+A2:2001, Graphical Symbols for use in the Labeling of Medical Devices Contact Person 

35 AAMI/ANSI/IEC 60601–1–2, Medical Electrical Equipment—Part 1–2: 

General Requirements for Safety—Collateral standard: Electromagnetic 

Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601–1–-2:2001 is the U.S. version of 

IEC 60601–1–2:2001, with identical requirements for electromagnetic 

compatibility (EMC) of medical electrical equipment.) 

Standard Organizations 

E. General Hospital/General Plastic Surgery 

114 ISO 11608–1:2000 Pen-injectors for Medical Use—Part 1: Peninjectors—Requirements and Test Methods Contact Person 

115 ISO 11608–2:2000 Pen-injectors for Medical Use—Part 2: Needles—Requirements and Test Methods Contact Person 

116 ISO 11608–3:2000 Pen-injectors for Medical Use—Part 3: Finished Cartridges—Requirements and Test Methods Contact Person 

66 and 162 ISO 8536–1:2006 Infusion Equipment for Medical Use—Part 1: Infusion 

Glass Bottles 

Withdrawn and replaced with 

newer version 

172 

53 ASTM D5151–99 (2006) Standard Test Method for Detection of Holes in 

Medical Gloves 

Withdrawn and replaced with 

newer version 

175 

77 ASTM F1862–05 Standard Test Method for Resistance of Medical Face 

Masks to Penetration by Synthetic Blood (Horizontal Projection of 

Fixed Volume at a Known Velocity) 

Withdrawn and replaced with 

newer version 

181 

80 ASTM E1112–00 (2006) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature Withdrawn and replaced with 

newer version 

177 

84 ASTM D6124–06 Standard Test Method for Residual Powder on Medical 

Gloves 

Withdrawn and replaced with 

newer version 

178 

161 ISO 10555–1:1995/ Amendment 1:1999, Amendment 2:2004 Sterile, Single-use Intravascular Catheters—Part 1: General Requirements Title 

85 ASTM 5250–06 Standard Specification for Poly(vinyl chloride) Gloves for 

Medical Application 

Withdrawn and replaced with 

newer version 

183 

E. In Vitro Diagnostics 

91 CLSI EP7–A2, Interference Testing in Clinical Chemistry; Approved 

Guidelines—Second Edition 

Withdrawn and replaced with 

newer version 

127 

F. Materials 

1 ASTM F67–06: Standard Specification for Unalloyed Titanium for Surgical 

Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS 

R50700) 

Withdrawn and replaced with 

newer version 

129 

2 ASTM F75–01: Standard Specification for Cobalt–28 Chromium–6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS 

R30075) 

Contact Person 

3 ASTM F90–01: Standard Specification for Wrought Cobalt–20 Chromium–15 Tungsten–10 Nickel Alloy for Surgical Implant Applications 

(UNS R30605) 

Contact Person 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

10 ASTM F603–00: Standard Specification for High-Purity Dense Aluminum 

Oxide for Surgical Implant Application 

Contact Person 

11 ASTM F620–06: Standard Specification for Alpha Plus Beta Titanium 

Alloy Forgings for Surgical Implants 

Withdrawn and replaced with 

newer version 

130 

15 ASTM F745–00: Standard Specification for 18 Chromium–12.5 Nickel–

2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications 

Contact Person 

26 ASTM F1314–01: Standard Specification for Wrought Nitrogen Strengthened 22 Chromium—13 Nickel—5 Manganese—2.5 Molybdenum 

Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) 

Contact Person 

27 ASTM F1341–99: Standard Specification for Unalloyed Titanium Wire 

UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical 

Implant Applications 

Withdrawn 

30 ASTM F1537–00: Standard Specification for Wrought Cobalt–28–Chromium–6–Molybdenum Alloy for Surgical Implants (UNS R31537, UNS 

R31538, and UNS R31539) 

Contact Person 

32 ASTM F1586–02: Standard Specification for Wrought Nitrogen Strengthened 21 Chromium–10 Nickel–3 Manganese–2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) Contact Person 

37 ASTM F1813–01: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS 

R58120) 

Contact Person 

41 ASTM F2066–01: Standard Specification for Wrought Titanium–15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) Contact Person 

43 ASTM F2146–01: Standard Specification for Wrought Titanium–

3Aluminum–2.5Vanadium Alloy Seamless Tubing for Surgical Implant 

Applications (UNS R56320) 

Contact Person 

44 ASTM F136–02a: Standard Specification for Wrought Titanium–6 Aluminum–4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) Contact Person 

45 ASTM F562–02: Standard Specification for Wrought 35Cobalt–35Nickel–

20Chromium–10Molybdenum Alloy for Surgical Implant Applications 

(UNS R30035) 

Contact Person 

46 ASTM F621–02: Standard Specification for Stainless Steel Forgings for 

Surgical Implants 

Contact Person 

47 ASTM F799–06: Standard Specification for Cobalt–28 Chromium–6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, 

R31539) 

Withdrawn and replaced with 

newer version 

131 

48 ASTM F899–02: Standard Specification for Stainless Steel for Surgical 

Instruments 

Contact Person 

49 ASTM F1058–02: Standard Specification for Wrought 40Cobalt–

20Chromium–16Iron–15Nickel–7Molybdenum Alloy Wire and Strip for 

Surgical Implant Applications (UNS R30003 and UNS R30008) 

Contact Person 

50 ASTM F1091–02: Standard Specification for Wrought Cobalt–20 Chromium–15 Tungsten–10 Nickel Alloy Surgical Fixation Wire (UNS 

R30605) 

Contact Person 

52 ASTM F1350–02: Standard Specification for Wrought 18 Chromium–14 

Nickel–2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS 

S31673) 

Contact Person 

53 ASTM F1472–02a: Standard Specification for Wrought Titanium 

-6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS 

R56400) 

Contact Person 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

54 ASTM F1580–01: Standard Specification for Titanium and Titanium–6 

Aluminum–4 Vanadium Alloy Powders for Coatings of Surgical Implants 

Contact Person 

56 ISO 5832–1:1997: Implants for Surgery—Metallic materials—Part 1: 

Wrought Stainless Steel 

Contact Person 

57 ISO 5832–2:1999: Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium Contact Person 

58 ISO 5832–3:1996: Implants for Surgery—Metallic Materials—Part 3: 

Wrought Titanium 6–Aluminium 4–Vanadium Alloy 

Contact Person 

59 ISO 5832–4:1996: Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum Casting Alloy Contact Person 

61 ISO 5832–6:1997: Implants for Surgery—Metallic Materials—Part 6: 

Wrought Cobalt-nickel-chromium-Molybdenum alloy 

Contact Person 

62 ISO 5832–9:1992: Implants for Surgery—Metallic Materials—Part 9: 

Wrought High Nitrogen Stainless Steel 

Contact Person 

63 ISO 5832–11:1994: Implants for Surgery—Metallic Materials—Part 11: 

Wrought Titanium 6–aluminium 7 niobium Alloy 

Contact Person 

64 ISO 5832–12:1996: Implants for Surgery—Metallic Materials—Part 12: 

Wrought Cobalt-chromium-molybdenum Alloy 

Contact Person 

66 ISO 6474:1994: Implants for Surgery—Ceramic Materials Based on High 

Purity Alumina 

Contact Person 

68 ISO 13782:1996: Implants for Surgery—Metallic Materials—Unalloyed 

Tantalum for Surgical Implant Applications 

Contact Person 

76 ASTM F138–03: Standard Specification for Wrought 18 Chromium–14 

Nickel–2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) 

Contact Person 

77 ASTM F139–03: Standard Specification for Wrought 18 Chromium–14 

Nickel–2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical 

Implants (UNS S31673) 

Contact Person 

79 ASTM F961–03: Standard Specification for Cobalt–35 Nickel–20 Chromium–10 Molybdenum Alloy Forgings for Surgical Implants [UNS 

R30035] 

Contact Person 

80 ASTM F1088–04ae1: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation Withdrawn and replaced with 

newer version 

132 

81 ASTM F1609–03: Standard Specification for Calcium Phosphate Coatings for Implantable Materials Contact Person 

82 ASTM F1713–03: Standard Specification for Wrought Titanium–13 Niobium–13 Zirconium Alloy for Surgical Implant Applications Contact Person 

85 ASTM F1854–01: Standard Test Method for Stereological Evaluation of 

Porous Coatings on Medical Implants 

Contact Person 

86 ASTM F1926–03: Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings Contact Person 

87 ASTM F1978–00e1: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber 

Abraser 

Contact Person 

88 ASTM F2024–00: Standard Practice for X-Ray Diffraction Determination 

of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings 

Contact Person 

89 ASTM F1873–98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications Contact Person 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

94 ASTM F601–03: Standard Practice for Fluorescent Penetrant Inspection 

of Metallic Surgical Implants 

Contact Person 

95 ASTM F629–02: Standard Practice for Radiography of Cast Metallic Surgical Implants Contact Person 

97 ASTM F2129–06: Standard Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices 

Withdrawn and replaced with 

newer version 

133 

98 ASTM F451–99ae1: Standard Specification for Acrylic Bone Cement Contact Person 

102 ASTM F2082–06: Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by 

Bend and Free Recovery 

Withdrawn and replaced with 

newer version 

134 

103 ASTM F1801–97(2004): Standard Practice for Corrosion Fatigue Testing 

of Metallic Implant Materials 

Contact Person and Type of 

Standard 

104 ASTM F1108–04: Standard Specification for Titanium–6Aluminum–

4Vanadium Alloy Castings for Surgical Implants (UNS R56406) 

Contact Person 

106 ASTM F648–04: Standard Specification for Ultra-High-Molecular-Weight 

Polyethylene Powder and Fabricated Form for Surgical Implants 

Contact Person 

107 ASTM F746–04: Standard Test Method for Pitting or Crevice Corrosion of 

Metallic Surgical Implant Materials 

Contact Person 

108 ASTM F1295–05: Standard Specification for Wrought Titanium–6 Aluminum–7 Niobium Alloy for Surgical Implant Applications (UNS 

R56700) 

Contact Person 

110 ASTM F1377–04: Standard Specification for Cobalt–28 Chromium–6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Contact Person 

111 ASTM F1160–05: Standard Test Method for Shear and Bending Fatigue 

Testing of Calcium Phosphate and Metallic Medical and Composite 

Calcium Phosphate/Metallic Coatings 

Contact Person 

112 ASTM F1044–05: Standard Test Method for Shear Testing of Calcium 

Phosphate Coatings and Metallic Coatings 

Contact Person 

113 ASTM F1147–05: Standard Test Method for Tension Testing of Calcium 

Phosphate and Metal Coatings 

Contact Person 

114 ASTM F2255–05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading Contact Person 

115 ASTM F2256–05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading Contact Person 

116 ASTM F2258–05: Standard Test Method for Strength Properties of Tissue Adhesives in Tension Contact Person 

117 ASTM F86–04: Standard Practice for Surface Preparation and Marking of 

Metallic Surgical Implants 

Contact Person 

119 ASTM F688–05: Standard Specification for Wrought Cobalt–35 Nickel–20 

Chromium–10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical 

Implants (UNS R30035) 

Contact Person 

120 ASTM F560–05: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Contact Person 

121 ASTM F2005–05: Standard Terminology for Nickel-Titanium Shape Memory Alloys Contact Person 

122 ASTM F2063–05: Standard Specification for Wrought Nickel-Titanium 

Shape Memory Alloys for Medical Devices and Surgical Implants 

Contact Person 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

123 ISO 5832–5:2005: Implants for Surgery—Metallic Materials—Part 5: 

Wrought Cobalt-chromium-tungsten-nickel Alloy 

Contact Person 

125 ASTM F2004–05: Standard Test Method for Transformation Temperature 

of Nickel-Titanium Alloys by Thermal Analysis 

Contact Person 

126 ASTM F561–05a: Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues Contact Person 

127 ISO 5834–2:1998: Implants for Surgery—Ultra-High-Molecular-Weight 

Polyethylene—Part 2: Moulded Forms 

Contact Person 

G. OB-GYN/Gastroenterology 

35 ASTM D6324–05 Standard Test Methods for Male Condoms Made from 

Synthetic Materials 

Withdrawn and replaced with 

newer version 

41 

H. Ophthalmic 

3 ISO 9340:1996 Optics and Optical Instruments—Contact lenses—Determination of Strains for Rigid Contact Lenses Withdrawn 

12 ISO 11980:1997 Ophthalmic Optics—Contact Lenses and Contact Lens 

Care Products—Guidance for Clinical Investigations 

Contact Person 

13 ISO 10942:2006 Ophthalmic Instruments—Direct Ophthalmoscopes Withdrawn and replaced with 

newer version 

37 

15 ISO 9394:1998 Ophthalmic Optics—Contact Lenses and Contact Lens 

Care Products—Determination of Biocompatibility By Ocular Study 

Using Rabbit Eyes 

Contact Person 

18 ISO 10943:2006 Ophthalmic Instruments—Indirect Ophthalmoscopes Withdrawn and replaced with 

newer version 

38 

20 ISO 11979–1:2006 Ophthalmic implants—Intraocular Lenses—Part 1: Vocabulary Withdrawn and replaced with 

newer version 

40 

23 ISO 11981:1999 Ophthalmic Optics—Contact Lenses And Contact Lens 

Care Products—Determination of Physical Compatibility of Contact 

Lens Care Products With Contact Lenses 

Contact Person 

24 ISO 11986:1999 Ophthalmic Optics—Contact Lenses and Contact Lens 

Care Products—Guidelines for Determination of Preservative Uptake 

and Release 

Contact Person 

34 ANSI Z80.20–2004 Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties Contact Person 

I. Orthopedic/Physical Medicine 

73 ISO 5838–1:1995: Implants for Surgery—Skeletal Pins and Wires—Part 

1: Material and Mechanical Requirements 

Contact Person 

74 ISO 5838–2:1991: Implants for Surgery—Skeletal Pins and Wires—Part 

2: Steinmann Skeletal Pins—Dimensions 

Contact Person 

75 ISO 5838–3:1993: Implants for Surgery—Skeletal Pins and Wires—Part 

3: Kirschner Skeletal Wires 

Contact Person 

79 ISO 7206–8:1995: Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 8: Endurance Performance of Stemmed Femoral Components With Application of Torsion Contact Person 

80 ISO 8828:1988: Implants for Surgery—Guidance on Care and Handling 

of Orthopaedic Implants 

Contact Person 

81 ISO 9583:1993: Implants for Surgery—Non-destructive Testing—Liquid 

Penetrant Inspection of Metallic Surgical Implants 

Contact Person 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

82 ISO 9584:1993: Implants for Surgery—Non-destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants Contact Person 

83 ISO 13402:1995: Surgical and Dental Hand Instruments—Determination 

of Resistance Against Autoclaving, Corrosion and Thermal Exposure 

Contact Person 

121 ISO 7207–1:1994: Implants for Surgery—Components for Partial and 

Total Knee Joint Prostheses—Part 1: Classification, Definitions and 

Designation of Dimensions 

Contact Person 

155 ISO 7207–2:1998: Implants for Surgery—Components for Partial and 

Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of 

Metal, Ceramic and Plastics Materials 

Contact Person 

163 ASTM F543–02e1, Standard Specification and Test Methods for Metallic 

Medical Bone Screws 

Withdrawn and replaced with 

newer version 

202 

166 ASTM F897–02: Standard Test Method for Measuring Fretting Corrosion 

of Osteosynthesis Plates and Screws 

Contact Person 

167 ASTM F1089–02: Standard Test Method for Corrosion of Surgical Instruments Contact Person 

168 ASTM F1781–03: Standard Specification for Elastomeric Flexible Hinge 

Finger Total Joint Implants 

Contact Person 

171 ASTM F1814–97a(2003): Standard Guide for Evaluating Modular Hip and 

Knee Joint Components 

Contact Person 

172 ASTM F1798–97(2003): Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies 

Used in Spinal Arthrodesis Implants 

Contact Person 

175 ASTM F1582–98(2003): Standard Terminology Relating to Spinal Implants Contact Person 

177 ASTM F1264–03: Standard Specification and Test Methods for 

Intramedullary Fixation Devices 

Contact Person 

178 ASTM F1440–92(2002): Standard Practice for Cyclic Fatigue Testing of 

Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion 

Contact Person 

179 ASTM F2068–03: Standard Specification for Femoral Prostheses—Metallic Implants Contact Person 

180 ASTM F366–04: Standard Specification for Fixation Pins and Wires Contact Person 

181 ASTM F1717–04: Standard Test Methods for Spinal Implant Constructs 

in a Vertebrectomy Model 

Contact Person 

182 ASTM F1800–04: Standard Test Method for Cyclic Fatigue Testing of 

Metal Tibial Tray Components of Total Knee Joint Replacements 

Contact Person 

183 ASTM F1875–98(2004): Standard Practice for Fretting Corrosion Testing 

of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper 

Interface 

Contact Person 

185 ASTM F2267–04: Standard Test Method for Measuring Load Induced 

Subsidence of an Intervertebral Body Fusion Device Under Static Axial 

Compression 

Contact Person 

186 ASTM F2077–03: Test Methods for Intervertebral Body Fusion Devices Contact Person 

187 ASTM F2193–02: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System Contact Person 

188 ISO 14243–1:2002: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 1: Loading and Displacement Parameters for Wear-testing Machines with Load Control and Corresponding Environmental 

Conditions for Test 

Contact Person 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

189 ISO 14243–2:2000: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 2: Methods of Measurement Contact Person 

190 ISO 14243–3:2004: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 3: Loading and Displacement Parameters for Wear-Testing Machines with Displacement Control and Corresponding Environmental Conditions for Test Contact Person 

191 ISO 14879–1:2000: Implants for Surgery—Total Knee-joint Prostheses—

Part 1: Determination of Endurance Properties of Knee Tibial Trays 

Contact Person 

192 ASTM F1223–05: Standard Test Method for Determination of Total Knee 

Replacement Constraint 

Contact Person 

J. Radiology 

34 IEC 60601–2–7 (1998) Medical Electrical Equipment—Part 2–7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators Contact Person 

68 NEMA MS 4–2006 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices Withdrawn and replaced with 

newer version 

151 

101 ANSI / IESNA RP–27.1–05 Recommended Practice for Photobiological 

Safety for Lamps and Lamp Systems—General Requirements 

Withdrawn and replaced with 

newer version 

153 

104 IEC 60601–2–33 (2006), Medical Electrical Equipment—Part 2–33: Particular Requirements for the Safety of Magnetic Resonance Equipment 

for Medical Diagnosis 

Withdrawn and replaced with 

newer version 

161 

111 ISO 11554:2006 Optics and Photonics—Lasers and Laser-Related equipment—Test Methods for Laser Beam Power, Energy and Temporal 

Characteristics 

Withdrawn and replaced with 

newer version 

155 

K. Software 

1 ISO/IEC 12207:1995 Information Technology—Software Life Cycle Processes Withdrawn 

3 IEEE/EIA 12207.0–1996 Industry Implementation of International Standard ISO/IEC 12207:1995(ISO/IEC 12207) Standard for Information 

Technology—Software Life Cycle Processes 

Withdrawn 

5 IEEE 1074–1997 Standard for Developing a Software Project Life Cycle 

Process 

Withdrawn 

6 IEEE 1012–2004 Standard for Software Verification and Validation Withdrawn 

7 AAMI / ANSI SW68:2001 Medical Device Software—Software Life Cycle 

Processes 

Withdrawn 

L. Sterility 

67 ASTM F1140–2005, Standard Test Methods for Internal Pressurization 

Failure Resistance of Unrestrained Packages for Medical Applications 

Withdrawn and replaced with 

newer version 

196 

68 ASTM F1585:2000, Standard Guide for Integrity Testing of Porous Barrier Medical Packages Withdrawn 

69 ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method Withdrawn and replaced with 

newer version 

197 

89 ASTM F2054–05, Standard Test Method for Burst Testing of Flexible 

Package Seals Using Internal Air Pressurization Within Restraining 

Plates 

Withdrawn and replaced with 

newer version 

198 

121 ASTM D4169–05, Standard Practice for Performance Testing of Shipping 

Containers and Systems 

Withdrawn and replaced with 

newer version 

199 

122 ASTM F88–2006, Standard Test Method for Seal Strength of Flexible 

Barrier Materials 

Withdrawn and replaced with 

newer version 

200 


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TABLE 2.—Continued 

Old Item 

No. Standard Change Replacement Item No. 

M. Tissue Engineering 

1 ASTM F2064–00(2006): Standard Guide for Characterization and Testing 

of Alginates as Starting Materials Intended for use in Biomedical and 

Tissue-Engineered Medical Products Application 

Withdrawn and replaced with 

newer version 

8 

III. Listing of New Entries 

In table 3 of this document, FDA 

provides the listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards under Recognition List 

Number: 017. 

TABLE 3. 

Item No. Title of Standard Reference No. & Date 

A. Anesthesia 

71 Lung Ventilators for Medical use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators ISO 10651–5:2006 

B. Cardiovascular/Neurology 

59 Implants for surgery—Cardiac Pacemakers—Part 3: Low-profile Connectors (IS–1) for 

Implantable Pacemakers 

ISO 5841–3:2000 

C. Dental/ENT 

140 Dental Base Metal Casting Alloys—Part 2: Nickel-based Alloys ISO 6871–2:1994/Amd 1:2005 

141 Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys ISO 6871–1:1994 

142 Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys ISO 6871–1:1994/Amd 1:2005 

D. General 

36 Technical Information Report: Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of 

Medical Devices, Second Edition 

ANSI/AAMI/ISO TIR 16142:2006 

E. General Hospital/General Plastic Surgery 

170 Sterile hypodermic syringes for single use—Part 1: Syringes for Manual Use ISO 7886–1:1993/ Corrigendum 1:1995 

171 Sterile, Single-use Intravascular Catheters- Part 3: Central Venous Catheters ISO 10555–3:1996/ Corrigendum 1:2002 

173 Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles ISO 8536–2:2001/ Corrigendum 1:2003 

174 Pen-injectors for Medical Use—Part 4: Requirements and Test Methods for Electronic 

and Electromechanical Pen-injectors 

ISO 11608–4:2006 

176 Standard Guide for Assessment of Medical Gloves ASTM D7103–06 

179 Needle-free Injectors for Medical Use—Requirements and Test Methods ISO 21649:2006 

180 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities ASTM F2407–06 

182 Medical Electrical Equipment— Part 2–38: Particular Requirements for the Safety of 

Electrically Operated Hospital Beds 

IEC 60601–2–38 1996/Amendment 

1:1999 

F. In Vitro Diagnostic 

128 Evaluation of Matrix Effects; Approved Guideline—Second Edition CLSI EP14–A2 2005 

129 Quality Control of Microbiological Transport Systems CLSI M40–A 2003 

G. Materials 

135 Standard Test Method for Burst Strength of Surgical Sealants ASTM F2392–04 

136 Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants ASTM F2458–05 


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TABLE 3.—Continued 

Item No. Title of Standard Reference No. & Date 

H. OB-GYN/Gastroenterology 

42 Medical electrical equipment—Part 2: Particular Requirements for the Safety of 

Endoscopic Equipment 

IEC 60601–2–18 (1996) Amendment 1 

2000 

43 Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of 

Natural Rubber Latex Condoms 

ISO 16038:2005 

I. Ophthalmic 

43 Ophthalmic Implants—Intraocular lenses—Part 8: Fundamental Requirements ISO 11979–8:2006 

J. Radiology 

150 Information Technology—Digital Compression and Coding of Continuous-tone Still 

Images—Part 1: Requirements and Guidelines 

IEC / ISO 10918–1:1994 Technical 

Corrigendum 1:2005 

152 Medical Electrical Equipment—Part 2–1: Particular Requirements for the Safety of 

Electron Accelerators in the Range 1 MeV to 50 MeV 

IEC 60601–2–1 (1998–06), Amendment 

1 2002 

154 Lasers and Laser-related Equipment—Determination of Laser-induced Damage 

Threshold of Optical Surfaces—Part 3: Assurance of Laser Power (energy) Handling Capabilities 

ISO 11254–3:2006 

156 Lasers and Laser-related Equipment—Test Methods for Laser Beam Parameters—

Beam Positional Stability 

ISO 11670:2003 Technical Corrigendum 

1:2004 

157 Optics and Optical Instruments—Lasers and Laser-related Equipment—Test Methods 

for Laser Beam Power (energy) Density Distribution 

ISO 13694:2000 Technical Corrigendum 

1:2005 

158 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging NEMA MS 10–2006 

159 Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance 

Imaging 

NEMA MS 11–2006 

160 Quantification and Mapping of Geometric Distortion for Special Applications NEMA MS 12–2006 

IV. List of Recognized Standards 

FDA maintains the agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

minor revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will announce additional 

modifications and minor revisions to 

the list of recognized consensus 

standards, as needed, in the Federal 

Register once a year, or more often, if 

necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the act by submitting 

such recommendations, with reasons for 

the recommendation, to the contact 

person (See FOR FURTHER INFORMATION

CONTACT). To be properly considered, 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard, (2) 

any reference number and date, (3) 

name and address of the national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

You may obtain a copy of ‘‘Guidance 

on the Recognition and Use of 

Consensus Standards’’ by using the 

Internet. CDRH maintains a site on the 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards related 

documents. After publication in the 

Federal Register, this notice 

announcing ‘‘Modifications to the List 

of Recognized Standards, Recognition 

List Number: 017’’ will be available on 

the CDRH home page. You may access 

the CDRH home page at http:// 

www.fda.gov/cdrh. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ through the hyperlink at 

http://www.fda.gov/cdrh/stdsprog.html. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.accessdata.fda.gov/scripts/ 

cdrh/cfdocs/cfTopic/cdrhnew.cfm. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic comments regarding this 

document. Two copies of any mailed 

comments are to be submitted, except 

that individuals may submit one paper 

copy. Comments are to be identified 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28511 

with the docket number found in 

brackets in the heading of this 

document. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

017. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: May 10, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–9718 Filed 5–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

A Method With Increased Yield for 

Production of Polysaccharide-Protein 

Conjugate Vaccines Using Hydrazide 

Chemistry 

Description of Technology: Current 

methods for synthesis and 

manufacturing of polysaccharideprotein conjugate vaccines employ 

conjugation reactions with low 

efficiency (about twenty percent). This 

means that up to eighty percent of the 

added activated polysaccharide (PS) is 

lost. In addition, inclusion of a 

chromatographic process for 

purification of the conjugates from 

unconjugated PS is required. 

The present invention utilizes the 

characteristic chemical property of 

hydrazide groups on one reactant to 

react with aldehyde groups or cyanate 

esters on the other reactant with an 

improved conjugate yield of at least 

sixty percent. With this conjugation 

efficiency the leftover unconjugated 

protein and polysaccharide would not 

need to be removed and thus the 

purification process of the conjugate 

product can be limited to diafiltration to 

remove the by-products of small 

molecules. The new conjugation 

reaction can be carried out within one 

or two days with reactant 

concentrations between 1 and 25 mg/mL 

at PS/protein ratios from 1:2 to 3:1, at 

temperatures between 4 and 40 degrees 

Centigrade, and in a pH range of 5.5 to 

7.4, optimal conditions varying from PS 

to PS. 

Application: Cost effective and 

efficient manufacturing of conjugate 

vaccines. 

Inventors: Che-Hung Robert Lee and 

Carl E. Frasch (CBER/FDA). 

Patent Status: U.S. Patent Application 

No. 10/566,899 filed 01 Feb 2006, 

claiming priority to 06 Aug 2003 (HHS 

Reference No. E–301–2003/0–US–10); 

U.S. Patent Application No. 10/566,898 

filed 01 Feb 2006, claiming priority to 

06 Aug 2003 (HHS Reference No. E–

301–2003/1–US–02); International 

rights available. 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

A Method of Immunizing Humans 

Against Salmonella Typhi Using a VirEPA Conjugate Vaccine 

Description of Technology: This 

invention is a method of immunization 

against typhoid fever using a conjugate 

vaccine comprising the capsular 

polysaccharide of Salmonella typhi, Vi, 

conjugated through an adipic 

dihydrazide linker to nontoxic 

recombinant exoprotein A (rEPA) from 

Pseudomonas aeruginosa. The three 

licensed vaccines against typhoid fever, 

attenuated S. typhi Ty21a, killed whole 

cell vaccines and Vi polysaccharide, 

have limited efficacy, in particular for 

children under 5 years of age, which 

make an improved vaccine desirable. 

It is generally recognized that an 

effective vaccine against Salmonella 

typhi is one that increases serum antiVi IgG eight-fold six weeks after 

immunization. The conjugate vaccine of 

the invention increases anti-Vi IgG, 48- 

fold, 252-fold and 400-fold in adults, in 

5–14 years-old and 2–4 years-old 

children, respectively. Thus this is a 

highly effective vaccine suitable for 

children and should find utility in 

endemic regions and as a traveler’s 

vaccine. The route of administration can 

also be combined with routine 

immunization. In 2–5 years old, the 

protection against typhoid fever is 90% 

for 4 years. In school age children and 

in adults the protection could mount to 

completer protection according to the 

immunogenicity data. 

Application: Immunization against 

Salmonella typhi for long term 

prevention of typhoid fever in all ages. 

Developmental Status: Conjugates 

have been synthesized and clinical 

studies have been performed. The 

synthesis of the conjugates is described 

by Kossaczka et al. in Infect Immun. 

1997 June;65(7):2088–2093. Phase III 

clinical studies are described by Mai et 

al. in N Engl J Med. 2003 October 2; 

349(14):1390–1391. Dosage studies are 

described by Canh et al. in Infect 

Immun. 2004 Nov;72(11):6586–6588. 

A safety and immunogenicity study in 

infants are underway. The aim is to 

administer the conjugate vaccine with 

routine infant immunization. 

Preliminary results show the vaccine is 

safe in 2 months old infants. 

Inventors: Zuzana Kossaczka, 

Shousun C. Szu, and John B. Robbins 

(NICHD). 

Patent Status: U.S. Patent 6,797,275 

issued 28 Sep 2004 (HHS Reference No. 

E–020–1999/0–US–02); U.S. Patent 

Application No. 10/866,343 filed 10 Jun 

2004 (HHS Reference No. E–020–1999/ 

0–US–03); U.S. Patent Application No. 

11/726,304 filed 20 Mar 2007 (HHS 

Reference No. E–020–1999/0–US–04). 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Child Health 

and Human Development, Laboratory of 

Developmental and Molecular 

Immunity, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize A Method of Immunizing 

Humans Against Salmonella Typhi 

Using a Vi-rEPA Conjugate Vaccine. 

Please contact John D. Hewes, Ph.D., at 

301–435–3121 or hewesj@mail.nih.gov 

for more information. 


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