FINAL DRAFT UGANDA 
STANDARD  
  FDUS 966-3 
First Edition  
2011 -mm-dd 
 
 
 Reference number  
FDUS 2011-3: 2011 
© UNBS 2011   
  
Medical devices  — Surgical gowns, drapes and clean air 
suits, — Part 3: Performance requirements and performance 
levels  
 FDUS 966-3: 2011  
ii © UNBS 2011  – All rights reserved  
 Compliance with this standard does not, of itself confer immunity from legal obligations  
A Uganda Standard does not purport to includ e all necessary provisions of a contract. Users are 
responsible for its correct application  
© UNBS 20 11  
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 m echanical, including photocopying and microfilm, without prior written 
permission 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 4 505 995  
Fax: 256 41 4 286 123  
E-mail: unbs@infocom.co.ug  
Web: www.unbs.go.ug  FDUS 966-3:2011  
© UNBS 2011  – All rights reserved  iii 
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Tourism, Trade and 
Industry establi shed under Cap 327 , of the Laws of Uganda.  UNBS is mandated to 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 Sta ndards, and  
(c) the National Enquiry Point on TBT/SPS Agreements 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 gi ven field or area and consists of representatives of 
consumers, traders, academicians, manufacturers, government and other stakeholders.  
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 recommending the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council.  
Committee membership  
The following organisations were represented on the Medical De vices Standards Technical Committee 
(UNBS/TC 16) during the development of this standard:  
 Government Analytical Laboratory  
 Joint Medical Stores (JMS)  
 Makerere University School of Publics Health (MUSPH)  
 Meridian Techsystem (MTS)  
 Ministry Of Health (MOH)  
 Mulago Hospital Complex  
 National Drug Authority (NDA)  
 National Medical Stores (NMS)  
 Paragon Hospital  
 Uganda National Bureau of Standards (UNBS)  
 FDUS 966-3: 2011  
iv © UNBS 2011  – All rights reserved  
 Introduction  
The series of US 966 specifies  requirements for single -use and reusable coverings (surgical gowns, surgical 
drapes and clean air suits) used as medical devices for patients, clinical staff and equipment and intended to 
prevent transmission of infected agents between patients and clinical staff during invasive  surgical 
procedures.  
The general requirement s for gowns, drapes and clean  air suits used as medical devices f or patients and 
clinical staff are specified in US 966 -1. In this respect, US 966 -1 specifies the relevant characteristics to be 
evaluated for products covered by the Uganda standard. US 966 -2 specifies the test methods for evaluating 
these characteristics.  
NOTE  For more information for products contained within the scope of this Uganda standard, it is 
recommended to refer to US 966 -1. 
 FINAL DRAFT UGANDA STANDARD  FDUS 966-3: 2011  
 
© UNBS 2011 – All rights reserved  1 
 Medical devices  — Surgical gowns, drapes and clean air s uits, 
used— Part 3: Performance requirements and performance 
levels  
1 Scope  
This part of FDUS 966 -3 specifies performance requirements for surgical drapes, gowns and clean air suits.  
Note  General performance requirements are specified for various characte ristics in US 966 -2, ISO 22610 and ISO 22612  
2 Normative references  
The following referenced documents are indispensable for the application 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.  
FDUS 966 -1, Medical devices — Surgical  gowns, drapes and clean air s uits, used as medical devices  — 
Part 1: General requirements  
FDUS 966 -2, Medical devices — Surgical gowns, drapes and clean air suits, used as medical devices for 
patients, clinical staff and equipment  — Part 2: Test methods   
ISO 9073 -11, Textiles – Test method for nonwovens – Part 11: Run off  
ISO 9073 -12, Textiles – Test method for nonwovens – Part 12: Demand absorbency  
ISO 15 223, Medical devices — Symbols to be used with medical device labels, labelling and information to be 
supplied  
ISO 11607 -1, Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile 
barrier systems and packaging sys tems  
ISO 11607 -2, Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for 
forming, sealing and assembly processes  
3 Terms and definitions  
For the purposes of this standard, the following terms and definitions shall apply .  
3.1  
less critical product area  
product area less likely to be involved in the transfer of infective agents to or from the wound  
NOTE 1 For the definition of critical product area, please see US 966 -1. 
NOTE 2 If the manufacturer differentiates between cr itical and less critical areas of the product, US 966 -1 requires the 
manufacturer to identify these areas, and if requested  should  supply information on the rationale for this distinction.  
3.2  
performance level  
refer to products designated as standard or  high performance according to close 4 of this standard  FDUS 966-3: 2011  
2 © UNBS 2011  – All rights reserved  
 NOTE  With the introduction of two performance levels, the US 966 series of standards acknowledges the fact that 
products are challenged to differing extents during surgical procedures, dependent upon the duration, mechanical stress 
and liquid challenge throughout the surgical procedure . 
3.2.1   
standard performance  
classification addressing minimum performance requirements for various characteristics of products (see 
clause 4) used as medical devices in  invasive surgical procedures  
3.2.2   
high performance  
classification addressing elevated performance requirements for various characteristics of products (see 
clause 4) used as medical devices in invasive surgical procedures  
NOTE Examples of surgical proce dure where elevated performance level should be considered are those 
where extensive exposure to liquid, mechanical stresses or those where longer procedures can be expected.  
3.3  
product  
surgical gowns, surgical drapes including equipment covering and cle an air suits  
4 Performance requirements  
To comply with the US 966 series of standards, products shall meet all the requirements specified in either 
Table 1, 2 or 3 (as appropriate to products), when tested according to US 966 -2 throughout their useful life . 
Note1  General Requirements  and guidance for manufacturers, processors and products, and the information to be supplied for the 
manufacturing, processing and testing are given in US 966 -1 
Note 2  Test methods for evaluation of all characteristics are given  in US 966 -2, ISO 22610 and ISO 22612  
Note 3  Performance requirements are specified depending on product area and performance level. However, for some 
characteristics, the performance requirement will apply for all performance levels and products areas of the medical device.  FDUS 966-3: 2011  
© UNBS 2011  – All rights reserved  3 
 Table  1 — Performance requirements for surgical gowns  
Characteristics  Units  Requirements  
Standard performance  High performance  
Critical product 
area Less critical 
product area  Critical product 
area Less critical 
product area  
Resistance to microbial 
penetration – dry Log 10 
(CFU)  Not required  ≤ 2 a, c Not required  ≤ 2 a, c 
Resistance to microbial 
penetration – wet  BI ≥ 2.8 b Not required  6.0 b d Not required  
Cleanliness – microbial  Log 10 
(CFU/dm2) ≤ 2 c ≤ 2 c ≤ 2 c ≤ 2 c 
Cleanliness - particulate 
matter  IPM ≤ 3.5 ≤ 3.5 ≤ 3.5 ≤ 3.5 
Linting  Log10 (lint 
count)  ≤ 4.0 ≤ 4.0 ≤ 4.0 ≤ 4.0 
Resistance to liquid 
penetration  Cm H 2O ≥ 20 ≥ 10 ≥ 100 ≥ 10 
Bursting strength – dry  kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40 
Bursting strength – wet  kPa ≥ 40 Not required  ≥ 40 Not required  
Tensile strength – dry  N ≥ 20 ≥ 20 ≥ 20 ≥ 20 
Tensile strength – wet  N ≥ 20 Not required  ≥ 20 Not required  
a  Test conditions: challenge concentration 10B CFU/g talc and 30 minutes vibration time  
b The least sig nificant difference (LSD) for BI (Barrier Index)  when estimated using ISO 22610 was found to be 0.98 at 98  % confidence 
level. This is the minimum difference need ed to distinguish between two materials thought to be different. Thus materials varying by up to 
0.98 BI are probably not different. Materials varying by more than 0.98  BI are probably different. (The 95  % confidence level means that 
an observer would be correct 19 times out of 20 to accept these alternatives)  
c  For the purpose of this standard, log 10 CFU ≤ 2 means maximum 300 CFU  
d BI (Barrier Index) = 6.0 for the purpose of this standard means; no penetration, B I = 6.0 is the maximum achievable value.  
 FDUS 966-3: 2011  
4 © UNBS 2011  – All rights reserved  
 Table  2 — Performance requirements for surgical drapes  
Characteristics  Units  Requirements  
Standard p erformance  High performance  
Critical 
product area  Less critical 
product area  Critical 
product area  Less critical 
product area  
Resistance to microbial 
penetration – dry Log 10 
(CFU)  Not required  ≤ 2 a, c Not required  ≤ 2 a, c 
Resistance to microbial 
penetration – wet  BI ≥ 2.8 b Not required  6.0 b d Not required  
Cleanliness – microbial  Log 10 
(CFU/dm2) ≤ 2 c ≤ 2 c ≤ 2 c ≤ 2 c 
Cleanliness - particulate 
matter  IPM ≤ 3.5 ≤ 3.5 ≤ 3.5 ≤ 3.5 
Linting  Log10 (lint 
count)  ≤ 4.0 ≤ 4.0 ≤ 4.0 ≤ 4.0 
Resistance to liquid 
penetration  Cm H 2O ≥ 20 ≥ 10 ≥ 100 ≥ 10 
Busting strength – dry  kPa ≥ 40 ≥ 40 > 40 ≥ 40 
Busting strength – wet  kPa ≥ 40 Not required  ≥ 40 Not required  
Tensile strength – dry  N ≥ 15 ≥ 15 ≥ 20 ≥ 20 
Tensile strength – wet  N ≥ 15 Not required  ≥ 20 Not required  
a  Test conditions: challenge concentration 108 CFU/g talc and 30 minutes vibration time  
b The least sig nificant difference (LSD) for BI  when estimated using ISO 22610 was found to be 0.98 at 98  % confidence level. This is the 
minimum diff erence need to distinguish between two materials thought to be different. Thus materials varying by up to 0.98 BI are 
probably not different. Materials varying by more than 0.98 BI are probably different. (The 95  % confidence level means that an observer 
would be correct 19 times out of 20 to accept these alternatives)  
c  For the purpose of this standard, log 10 CFU ≤ 2 means maximum 300 CFU  
d BI (Barrier Index)  = 6.0 for the purpose of this st andard means; no penetration, BI  = 6.0 is the maximum achievable value.  
 FDUS 966-3: 2011  
© UNBS 2011  – All rights reserved  5 
 Table  3 — Performance requirements for clean air suit s 
Characteristics  Unit Requirement b 
Resistance to microbial penetration – dry Log 10 (CFU)  ≤ 2 a c 
Cleanliness – microbial  Log 10 (CFU/dm2) ≤ 2 C 
Cleanliness – particulate matter  IPM  ≤ 3.5 
Linting  Log10 (lint count)  ≤ 4.0 
Busting strength – dry kPa ≥ 40 
Tensile strength – dry N ≥ 20 
a  Test conditions: challenge concentration 108 CFU/g talc and 30 minutes vibration time  
b Performance requirements apply for all areas of clean air suits, a s clean air suits should be used in addition to surgical 
gowns and not as substitute.  
c  For the purpose of this standard, log 10 CFU ≤ 2 means maximum 300 CFU  
 
5 Packing and marking  
5.1 Packing  
The number of products per package and the type of package sh all be as specified by the purchaser. The 
packages shall be packed in accordance with ISO 11607  series.  Only products of the same type and nominal 
size shall be packed together in a package and in a bulk container. Sterile -packed packages shall be packed 
in separate bulk containers.  
5.2 Marking  
5.2.1  Packages  
In addition to the requirements of US 966 -1 (clause 4), t he following information shall appear in legible and 
indelible marking on each package of product or on a label securely attached to the package : 
a) the manufacturer's name, address and trade mark;  
b) the name of product ; 
c) in the c ase of a sterile -package , the word "sterile";  
d) the quantity of product ;  
e) the batch identification number;  
f) date of manufacture  and conditions of storage  
g) country of origin  
5.2.2  Additional marking  
When so specified by the purchaser, packa ges shall bear information additional to that requi red in terms of 
5.2.1. 
 FDUS 966-3: 2011  
6 © UNBS 2011  – All rights reserved  
 Bibliography  
[1] EN 13795 -2, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical 
staff and equipments – Part 2: Test methods  
[2] ISO 22612, Clothing for protecti on against infectious agents – Test method for resistance to dry 
microbial penetration  
 
 FDUS 966-3: 2011  
© UNBS 2011 – All rights reserved  7 
 Certification marking  
Products that conform to Uganda standards may be marked with Ugan da 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 certi fication 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 pa rticulars of the terms and conditions of licensing may be obtained from the Director, Uganda 
National Bureau of Standards.  
 
 FDUS 966-3: 2011    
 
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