DRAFT UGANDA STANDARD  
  DUS 2011  
First  Edition  
2018 -mm-dd 
 
 
 Reference number  
DUS 2011 : 2018 
© UNBS 2018   
  
Sterile s urgical blades  — Specification   
 DUS 2011 : 2018  
ii © UNBS 2018  – All rights reserved  
 Compliance with this standard does not, of itself confer immunity from legal obligations  
A Uganda Standard does not purport to include all necessary provisions of a contract. Users are 
responsible for its correct  application  
© UNBS 2018   
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any 
form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written 
permissio n from UNBS.  
Requests for permission to reproduce this document should be addressed to  
The Executive Director  
Uganda National Bureau of Standards  
P.O. Box 6329  
Kampala  
Uganda  
Tel: +256 41 4 333 2 50/1/2/3  
Fax: +256 41 4 286 123  
E-mail: info@unbs.go.ug  
Web: www.unbs.go.ug  DUS 2011 :2018  
© UNBS 2018  – All rights reserved  iii 
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade , Industry and 
Cooperatives established under Cap 327 , of the Laws of Uganda , as amended .  UNBS is mandated t o co-
ordinate the elaboration of standards and is  
(a) a member of International Organisation for Standardisation (ISO) and  
(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT  Agreement  of the World Trade Organisation (WTO).  
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberate on standards in a given field or area and consists of key stakeholders 
including govern ment, academia, consumer groups, private sector and other interested parties.  
Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders and the 
general public for comments. The committee reviews the comments before re commending the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council.  
The committee responsible for this document is Technical Committee UNBS /TC 14, Medical devices . 
 DRAFT UGANDA STANDARD  DUS 2011 : 2018  
 
© UNBS 2018 – All rights reserved  1 
 Sterile surgical blades  — Specification  
1 Scope   
This Draft Uganda standard specifies the requirements, method s of test and sampling of sterile surgical 
blades . 
2 Normative references   
The following referenced documents referred to in the text in such a way that some or all of their content 
constit utes requirements of this document. For dated references, only the edition cited applies. For undated 
references, the latest edition of the referenced document (including any amendments) applies.  
ASTM A 751 -14a, Standard Test Methods, Practices, and Termin ology for Chemical Analysis of Steel 
Products  
DUS ISO 7740 , Instruments for surgery -- Scalpels with detachable blades -- Fitting dimensions  
DUS ISO 13402, Surgical and dental hand instruments -- Determination of resistance against autoclaving, 
corrosion a nd thermal exposure  
ISO 2859 -1, Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by 
acceptance quality limit (AQL) for lot -by-lot inspection  
US ISO 6508 -1, Metallic materials — Rockwell hardness test — Part 1: Test metho d 
3 Terms and definitions   
For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain 
terminological databases for use in standardization at the following addresses: — ISO Online browsing 
platform: available at http://www.iso.org/obp  
3.1  
burr 
Piece  of metal projection not normally inherent to smooth uniform surfac e. 
3.2  
feather  
thin, turned ,projecting or curled edge not removed by honing or buffing  
3.3 
incision  
surgical cut made in skin or flesh  
3.4 
jag 
several small tooth -like projections or similar indentations, individually smaller than nicks.  DUS 2011:2018  
2 © UNBS 2018  – All rights reserved  
 3.5 
nick 
chipped -out, broken -out, indented or bent -out piece of metal or any similar gap  or indentation  
3.6 
surgical blade  
blades used for cutting skin and tissue during su rgical procedures  
3.7 
waviness  
undulation of cutting edge.  
4 Requirements  
4.1 General requirements  
4.1.1 The blade shall be highly polished and free from any blemishes. All edges, other than the cutting 
edge, shall be rounded. The edges other than the cutt ing shall not be sharp.  
4.1.2 The blade shall be made of  surgical grade 316 stainless steel .  
4.1.3  The tip of the blade shall be well defined and sharp.  
4.1.4  There shall be no waviness, jags, feathers,  burrs,  nicks or other defects on the cutting edge when 
examined in under a magnification of 10X . 
4.1.5   The surgical blade shall have a slot and both surfaces of the blade and all sides of the slot shall be 
uniform, free from roughness, waviness and shall not show any sign of corrosion or rust.  
4.2 Quality requirements  
4.2.1  Chemical composition  
4.2.1  The surgical blade shall conform to one of the following  composition  given in table 1 when tested in 
accordance with  the test method given therein.  
Table 1 — Chemical composition for stainless grade 316 steel s urgical blade  
Element  Percentage  Test methods  
Carbon , max 0.08   
 
 
ASTM A 751 -14a Manganese , max 2.0  
Phosphorus ,max 0.045  
Sulphur , max 0.03  
Silicon , max 0.75  
Chromium  16-18 
Nickel  10 - 14 
Nitrogen  0.10 - 0.16 
Molybdenum  2-3 DUS 2011 : 2018  
© UNBS 2018  – All rights  reserved  3 
 4.2.2 Surgical blade number  
The surgical blade shall be classified according to  surgical  blade numbers. The thickness of the fitting area of 
the blade shall be between 0.37mm and 0.42mm.  
4.2.3 Hardness  
When tested in accordance with US ISO 6508 -1, the hardness  of the surgical blade  shall not exceed 95 
Rockwell HB   
4.2.4 Corrosion resistant  
The blade shall not show any red stains or spots when examined with copper sulphate test given in DUS ISO 
13402.  
4.2.5 Blade handle fitment.  
The blade handle fitment shall co nform to DUS ISO 7740 specifications.  
4.3 performance test  
When examined in accordance with annex A, the surgical blade shall cut easily and cleanly along the entire 
length of the cutting edge. On completion of the test, the blade shall show no sign of dam age when examined 
under magnification 10X . 
5 Sterility  
The surgical blade shall be sterile when tested in accordance with annex B.  
6 Packaging  
6.1 The blad es shall be individually packaged in aluminium foil peel back with VC paper which shall maintain 
the blade in its sterile state until when opened.  
6.2 The primary packaged shall be tested for  
6.3 A number of individually packed surgical blade may be packaged in a box.  
7 Labelling  
7.1 Surgical blade  
The surgical blade shall be legibly and indelibly  marked  with the following:  
a) Blade number  
b) the word stainless steel or (SS) ; and  
c) manufacturer’s  code  
7.2 Primary package  
The primary package shall be legibly and indelibly marked with the following information  DUS 2011:2018  
4 © UNBS 2018  – All rights reserved  
 1) Manufacturer’s name and /or trade mark ; 
2) name of product , “surgical blade” ; 
3) country of origin ; 
4) material used “stainless steel”  or (SS) , 
5) sterile ; 
6) sterilisation method ; 
7) blade number ; 
8) batch number ; 
9) cautions like “ don’t use if found open”  and “single use only” ; and  
10) date of manufacture and expiry.  
7.3 second ary package  
The secondary package shall be legibly and indelibly marked with the following information : 
i) Name and address of the manufacturer/ packer/distributor;  
ii) name of product;  
iii) surgical blade number , 
iv) sterile;  
v) sterilisation method ; 
vi) country of origin ; 
vii) number of surgical blades packed ; 
viii) batch number;  
ix) date of Manufacture and expiry; and  
x) pictorial of the surgical blade,  
8 Sampling  
Sampling shall be done in accordance with ISO 2859 -1. DUS 2011 : 2018  
© UNBS 2018  – All rights  reserved  5 
 Annex  A 
(normative)  
 
performance test.  
A.1 procedure  
A.1 Cut a piece of  curried leather 5 mm thick with moderate pressure using a surgical blade five times  100 
mm long . 
A.2 Examine the surgical blade under the magnification of 10X.  DUS 2011:2018  
6 © UNBS 2018  – All rights reserved  
 Annex B  
(normative)  
 
Sterility  
B.1 Introduction  
The following culture media have been found to  be suitable for the test for sterility. Fluid thioglycollate medium 
is primarily intended for the culture of anaerobic bacteria; however, it will also detect aerobic bacteria. Soya -
bean casein digest medium is suitable for the culture of both fungi and ae robic bacteria.  
B.2 Fluid thioglycollate medium  
L-Cystine                   0.5 g  
Agar                    0.75 g  
Sodium chloride                  2.5 g  
Glucose monohydrate/anhydrous              5.5 g/5.0 g  
Yeast extract (water -soluble)               5.0 g  
Pancreatic digest of casein                15.0 g  
Sodium thioglycollate or                0.5 g  
Thioglycollic acid                  0.3 mL  
Resazurin sodium solution (1g/L of resazurin sodium), freshly prepared      1.0 mL  
Water R                    1000 mL  
pH after sterili sation                 7.1 ± 0.2  
B.2.1 Mix the L -cystine, agar, sodium chloride, glucose, water -soluble yeast extract and pancreatic digest of 
casein with the water R and heat until solution is effected.  
B.2.2 Dissolve the sodium thiog lycollate or thioglycollic acid in the solution and, if necessary, add 1 M 
sodium hydroxide so that, after sterilisation, the solution will have a pH of 7.1 ± 0.2. If filtration is necessary, 
heat the solution again without boiling and filter while hot thr ough moistened filter paper.  
B2.3 Add the resazurin sodium solution, mix and place the medium in suitable vessels which provide a ratio 
of surface to depth of medium such that not more than the upper half of the medium has undergone a colour 
change indica tive of oxygen uptake at the end of the incubation period. Sterilise using a validated process. If 
the medium is stored, store at a temperature between 2 °C and 25 °C in a sterile, airtight container.  
B.2.4 If more than the upper one -third of the medium h as acquired a pink colour, the medium may be 
restored once by heating the containers in a water -bath or in free - flowing steam until the pink colour 
disappears and cooling quickly, taking care to prevent the introduction of non -sterile air into the contain er. Do 
not use the medium for a longer storage period than has been validated.Fluid thioglycollate medium is to be 
incubated at 30 -35 °C.  DUS 2011 : 2018  
© UNBS 2018  – All rights  reserved  7 
 B.2.5 For products containing a mercurial preservative that cannot be tested by the membrane -filtration 
method, fluid thioglycollate medium incubated at 20 -25 °C may be used instead of soya -bean casein digest 
medium provided that it has been validated as described in growth promotion test.  
B.3 Alternative thioglycollate medium  
Where prescribed or justified and authorise d, the following alternative thioglycollate medium may be used. 
Prepare a mixture having the same composition as that of the fluid thioglycollate medium, but omitting the 
agar and the resazurin sodium solution, sterilise as directed above. The pH after ste rilisation is 7.1 ± 0.2. Heat 
in a water -bath prior to use and incubate at 30 -35 °C under anaerobic conditions.  
B.4 Soya -bean casein digest medium  
Pancreatic digest of casein           17.0 g  
Papaic digest of soya -bean meal         3.0 g  
Sodium chloride             5.0 g  
Dipotassium hydrogen phosphate         2.5 g  
Glucose monohydrate/anhydrous         2.5 g/2.3 g  
Water R               1000 mL  
pH after sterilization            7.3 ± 0.2  
B.4.1 Dissolve the solids in water R, warming slightly to effect sol ution. Cool the solution to room 
temperature. Add 1 M sodium hydroxide, if necessary, so that after sterilisation the solution will have a pH of 
7.3 ± 0.2.  
B.4.2 Filter, if necessary, to clarify, distribute into suitable vessels and sterilise using a vali dated process. 
Store at a temperature between 2 °C and 25 °C in a sterile well -closed container, unless it is intended for 
immediate use. Do not use the medium for a longer storage period than has been validated. Soya -bean 
casein digest medium is to be inc ubated at 20 -25 °C.  
The media used comply with the following tests, carried out before or in parallel with the test on the product to 
be examined.  
B.5 Sterility  
Incubate portions of the media for 14 days. No growth of micro -organisms occurs.  DUS 2011:2018  
8 © UNBS 2018  – All rights reserved  
 Annex  C 
(informative)  
 
common surgical blade number  
C.1 Number 10 blade  
It has a large curved cutting edge. It is one of the more traditional blade shapes used for making large 
incisions and cuttings.  
C.2 Number 11 bl ade 
It is an elongated, triangular blade sharpened along the hypotenuse edge. It has a pointed tip making it ideal 
for stab incisions and precise short cuts in shallow recessed areas.  
C.3 Number 12 blade  
It is a small, pointed crescent -shaped blade sharpen ed along the inside edge of the curve. It is sometimes 
used as suture cutter.  
C.4 Number  15 blade  
It has a small curved cutting edge. It is ideal for making short precise incisions.  
C.5 Number 20 blade  
The No.20 is a large version of the No.10 blade with a  curved cutting edge and a flat, unsharpened back 
edge.  It is u sed for orthopaedic and general surgical procedures.  
C.6  Number 22 blade  
It is larger version of number 10 blade with curved cutting edge and flat unsharpened back edge. It is often 
used crea ting large incisions through thick skin.  
C.7 Number 2 3 blade  
The No.23 is a "leaf -shaped" blade sharpened along its leading edge. Used for making long incisions such as 
an upper midline incision of the abdomen during the repair of a perforated gastric ulce r. 
C.8 Number 2 4 blade  
Slightly larger than the No.23 blade, the No.24 is more semi -circular in shape and is again sharpened along its 
leading edge. Used for making long incisions in general surgery and also in autopsy procedures  DUS 2011 : 2018  
© UNBS 2018  – All rights  reserved  9 
 C.9 Number 2 5 blade  
A fro nt-facing straight blade with flat back  
 
 
 
Figure C 1 —  some illustrution for surgical blade number.  
DUS 2011:2018  
10 © UNBS 2018  – All rights reserved  
 Annex D 
(informative )  
 
Surgical blade parts  
 
Figure D— General parts of a surgical blade.  
 DUS 2011 : 2018  
© UNBS 2018  – All rights  reserved  11 
 Bibliography  
[1] ASTM A240/A240M – 17, Standard Specification fo r Chromium and Chromium -Nickel Stainless Steel 
Plate, Sheet, and Strip for Pressure Vessels and for General Applications  
[2] IS 3319, 1995, Blades, Surgical, Detachable (Bard Parker Type) and Handles - Specification (fourth 
revision)  
[3] ISO 11135 (both p arts), Sterilization of health care products — Ethylene oxide   
[4] ISO 11137 (all parts), Sterilization of health care products — Radiation   
[5] ISO 17665 (all parts), Sterilization of health care products — Moist heat  
[6] ISO 19000:2015, Quality managemen t systems  
 DUS 2011 : 2018  
© UNBS 2018 – All rights reserved  13 
 Certification marking  
Products that conform to Uganda standards may be marked with Uganda National Bureau of Standards 
(UNBS) Certification Mark shown in the figure below.  
The use of the UNBS Certification Mark is governed by the Standards Act , and the Regulations made 
thereunder. This mark can be used only by those licensed under the certification mark scheme operated by 
the Uganda National Bureau of Standards and in conjunction with the relevant Uganda Standard. The 
presence of this mark on a  product or in relation to a product is an assurance that the goods comply with the 
requirements of that standard under a system of supervision, control and testing in accordance with the 
certification mark scheme of the Uganda National Bureau of Standards . UNBS marked products are 
continually checked by UNBS for conformity to that standard.  
Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda 
National Bureau of Standards.  
 
 DUS 2011 : 2018    
 
ICS 11.040.30  
Price based on nn pages  
© UNBS 2018 – All rights reserv ed