FINAL DRAFT UGANDA 
STANDARD  
  FDUS 966-1 
First Edition  
2011 -mm-dd 
 
 
 Reference number  
FDUS 966-1: 2011 
© UNBS 2011   
  
Medical devices — Surgical gowns, drapes and clean air 
suits — Part 1: General requirements  
 FDUS 966-1: 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 include 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 mechanical, including photoc opying 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: 25 6 414 286 123  
E-mail: unbs@infocom.co.ug  
Web: www.unbs.go.ug  FDUS 966-1:2011  
© UNBS 2011  – All rights reserved  iii 
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Tourism, Trade and 
Industry established 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 Standards, and  
(c) the National E nquiry 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 given field or area and consi sts 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 Devices Standards Technical C ommittee  
(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  
 Natio nal Drug Authority (NDA)  
 National Medical Stores (NMS)  
 Paragon Hospital  
 Uganda National Bureau of Standards (UNBS)  
 FDUS 966-1: 2011  
iv © UNBS 2011  – All rights reserved  
 Introduction  
The transmission of infective agents during invasive surgical procedures can occur in several ways (see 
Annex C).  Surgical dra pes, gowns and clean air suits are used to minimize the spread of infective agents to 
and from patients’ operating wounds, thereby helping to prevent post -operative wound infections (see Annex  
C). The performance required of coverings for patients, clinica l staff and equipment varies with, for example, 
the type and duration of the procedure, the degree of wetness of the operation field, the degree of mechanical 
stress on the materials and the susceptibility of the patient to infection.  
The use of surgical g owns with resistance to the penetration of liquids can also diminish the risk to the 
operating staff from blood -borne infective agents carried in blood or body fluids.  
The US 966  series of Uganda  Standards, together with ISO 22610  and ISO 22612 , is intende d to assist the 
communication between users, manufacturers and third party verifiers with regard to material or product 
characteristics. it focuses on relevant essential requirements to guarantee safety and performance of a 
medical device. the general requ irements and guidance in us 966 -1 are expected to be of help to 
manufacturers, test houses and users when designing, processing, assessing and selecting products. It is the 
intention of US 966  to ensure the same level of safety from single -use and reusable  surgical clothing and 
drapes throughout their useful life  
 
 FINAL DRAFT UGANDA STANDARD  FDUS 966-1: 2011  
 
© UNBS 2011 – All rights reserved  1 
 Medical devices — Surgical gowns, drapes and clean air 
suits — Part 1: General requirements  
1 Scope  
This Final  Draft Uganda Standard specifies information to be supplied to users and third part y verifiers, in 
addition to the usual labelling of medical devices ( ISO 15223 ), concerning  manufacturing and processing 
requirements. This standard gives general guidance on the characteristics of single -use and reusable surgical 
gowns, surgical drapes and  clean air suits used as medical devices for patients, clinical staff and equipment. It 
is intended to prevent the transmission of infective agents between patients and clinical staff during surgical 
and other invasive procedures.  This standard does not in clude th e requirements for incision drapes . 
This standard does not cover requirements for flammability of products used in laser surgery. Suitable test 
methods for flammability and resistance to penetration by laser radiation, together with an appropriate 
classification system, are given in ISO 11810 . 
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 editio n of the referenced 
document (including any amendments) applies.  
ISO 15223, 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 systems  
ISO 11607 -2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for 
forming, sealing and assembly processes  
ISO 11737 -1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a 
population of microorganisms on products  
ISO 11737 -2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed 
in the definition, validation and mainten ance of a sterilization   
3 Terms and definitions  
For the purposes of this standard, the following terms and definitions shall apply . 
3.1  
clean air suit  
suit intended and shown to minimize contamination of the operating wound by the wearer's skin scales 
carrying infective agents via the operating room air thereby reducing the risk of wound infection  
NOTE  Unlike the suit usually worn in the operation room, the clean air suit is designed to reduce the operating room 
air contamination by personnel  
3.2  
cleanli ness  
freedom from unwanted foreign matter  FDUS 966-1: 2011  
2 © UNBS 2011  – All rights reserved  
 NOTE  Such matter can be micro -organisms, organic residues or particulate matter.  
3.2.1  
cleanliness — microbial  
freedom from population of viable micro -organisms on a product and/or a package  
NOTE  In practical use microbial cleanliness is often referred to as “bioburden“  
3.2.2  
cleanliness — particulate matter  
freedom from population  freedom from particles that are contaminating a material and can be released but are 
not generated by mechanical impact.  
3.3  
critical  product area  
product area with a greater probability to be involved in the transfer of infective agents to or from the wound, 
for example, front and sleeves of surgical gowns . 
3.4  
drapeability  
ability of a material to conform to a given shape or object  
3.5  
fabric  
cloth made from yarn or fibres by weaving, knitting and/or other types of binding or manufacture  
3.6  
fixation  
adhesion of a surgical drape to the patient for the purpose of wound isolation  
NOTE  See Annex B . 
3.7 
infective agent  
micro -organism th at has been shown to cause a wound infection or that might cause infection in a member of 
the surgical team or the patient  
3.8 
linting  
release of fibre fragments and other particles during handling and use  
NOTE  These fragments and particles are originally from the fabric itself . 
3.9 
manufacturer  
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device 
before it is placed on the market under his own name, regardless of whether these operations are carried o ut 
by that person himself or on his behalf by a third party  
3.10 
processor  
natural or legal person who processes reusable product items so that their performance complies with the 
requirements of this standard  
NOTE  A processor who places a product on the m arket is a manufacturer in the sense of this standard.  
3.11 
resistance to liquid penetration  
ability of material to resist the penetration of liquid(s) from one side of the material through to the other  FDUS 966-1: 2011  
© UNBS 2011  – All rights reserved  3 
 3.12 
resistance to microbial penetration  
ability of m aterial(s) to withstand penetration of micro -organisms from one side through to the other  
3.12.1  
dry penetration  
effect of a combination of air movement and mechanical action by vibration on microbial penetration in dry 
condition  
3.12.2  
wet penetration  
effect of combination of wetness, pressure and rubbing on microbial penetration  
3.13 
reusable product  
product intended by the manufacturer to be reprocessed and reused  
3.14 
single -use product  
product intended by the manufacturer to be used for only one surgic al procedure before disposal  
3.15 
surgical drape  
drape covering the patient or equipment to prevent transfer of infective agents  
3.16 
surgical gown  
gown worn by a member of a surgical team to prevent transfer of infective agents  
3.17 
surgical procedure  
surgical intervention penetrating skin or mucosa, performed by a surgical team  
3.17.1  
clean operation  
operation performed on uninfected, non -traumatised tissue and in which respiratory, alimentary or genito -
urinary tracts are not entered  
3.17.2  
infection -pron e operation  
operation where the nature of the operation or the condition of the patient is such that infection can occur with  
minimal contamination  
3.17.3  
invasive surgical procedure  
procedure that reaches the inside of the body through the body surface  
3.18 
water -vapour resistance  
water -vapour pressure difference between the two faces of a material divided by the resultant evaporative 
heat flux per unit area in the direction of the gradient. The evaporative heat flux can consist of both diffusive 
and conve ctive components  
4 Information to be supplied by the manufacturer or processor  
4.1 The following information shall be supplied:  FDUS 966-1: 2011  
4 © UNBS 2011  – All rights reserved  
 a) if the device is intended by the manufacturer to be reused, information on the appropriate processes 
to allow reuse, including c leaning, disinfection, packing and, if appropriate, the methods of sterilization 
of the device to be re -sterilized, the number of reuses and any restriction to the reuse;  
b) if the device is supplied with the intention that it be sterilized before use, instru ctions for sterilization 
methods;  
c) if the manufacturer differentiates between critical and less critical areas of the product, the 
identification of these areas; and  
d) instructions for disposal after the useful life of the product  
4.2 The following informatio n shall be supplied  on request  
a) the identity or information on the test methods used;  
b) the results of testing for the characteristics given in tables 1, 2 and 3;  and 
c) if the manufacturer differentiates between critical and less critical areas of the product, the rationale 
for this distinction  
Table  1 — Characteristics to be evaluated for surgical gowns  
Characteristics  
Resistance to microbial penetration – Dry 
Resistance to microbial penetration – Wet 
Cleanliness – Microbial  
Cleanliness – Particulate matter  
Linting  
Resistance to liquid penetration  
Bursting strength – Dry 
Bursting strength – Wet 
Tensile strength – Dry 
Tensile strength – Wet 
 FDUS 966-1: 2011  
© UNBS 2011  – All rights reserved  5 
  
Table  2 — Characteristics to be evaluated for surgical drapes  
Characteristics  
Resistance to microbial penetr ation – Dry 
Resistance to microbial penetration – Wet 
Cleanliness – Microbial  
Cleanliness – Particulate matter  
Linting  
Resistance to liquid penetration  
Bursting strength – Dry 
Bursting strength – Wet 
Tensile strength – Dry 
Tensile strength – Wet 
Adhesion for fixation for the purpose of wound isolation  
See Annex B  
 
Figure  3 — Characteristics to be evaluated for clean air suits  
Characteristics  
Resistance to microbial penetration – Dry 
Cleanliness – Microbial  
Cleanliness – Particulate matter  
Linting  
Bursting strength – Dry 
Tensile strength – Dry 
 
 
5 Manufacturing and processing requirements  
5.1 The manufacturer and processor shall be able to demonstrate that the requirements set down in this 
series of standards are met and that the fitness fo r purpose has been established for each use, both for single 
and reusable medical devices.  
NOTE A quality system su ch as ISO 13485, ISO 13488, ISO 14969, is recommended . 
5.2 Validated manufacturing and processing procedures shall be used.  
5.2.1  A manufactu ring and processing specification shall be designed and validated for the product, 
including visual and hygienic cleanliness.  
5.2.2  The validation shall include all steps of manufacture and processing.  FDUS 966-1: 2011  
6 © UNBS 2011  – All rights reserved  
 5.2.3  The frequency of revalidation shall be determine d during validation and shall be reassessed after any 
change of manufacturing or processing that could materially affect the product.  
5.2.4  The key manufacturing and process variables shall be identified, monitored and recorded. The type 
and frequency of r outine monitoring shall be documented.  
5.2.5  The results of the validation and routine monitoring shall be recorded and retained.  
NOTE For validation and monitoring processes quantitative biological, chemical and/or physical tests are preferred.  
5.3 During  manufacturing and processing, the control of decontamination and disinfecting procedures and 
the traceability of sterilisation shall be maintained.  
5.4 It shall be possible to demonstrate that the properties of the materials have been maintained during  
manufacture and processing  
6 Testing requirements  
6.1 It shall be possible to demonstrate that the requirements of this series of standards are met. All test 
results  shall be recorded and retained.  
6.2 The finished product shall be tested, prior to its first  being placed on the market. If the product is to be 
used  after sterilisation, the test shall be performed on products after sterilisation with the exception of 
microbial  cleanliness. Testing shall include potential weak spots.  
NOTE 1 Performance requireme nts can vary in relation to the areas of the product and the risk of involvement in the 
transfer  of infective agents to or from the wound. Minimum performance requirements will be given in EN 13795 -3 for 
critical product  areas and less critical product are as. Test methods will be given in US 966 -2, ISO  22610 and ISO  22612 
(see Foreword).  
NOTE 2 To ensure product performance, combinations of materials or products in systems can be used.  
NOTE 3 In cases of surgical packs, each gown, drape or clean air suit is  regarded as a product.  
6.3 During manufacture and processing, testing shall be conducted according to the requirements of the  
manufacturer's and processor's quality system.  
6.4 Until such time that standardised or widely accepted validated tests are avail able, the applied test 
method  shall have been validated and documented.  
6.5 Alternative te st methods for monitoring (see 5 .2) may be used provided that they address the same  
characteristic and that the results are shown to correlate with the test methods g iven in this series of 
standards.  
 FDUS 966-1: 2011  
© UNBS 2011  – All rights reserved  7 
 Annex  A 
(informative)  
 
Comfort  
A.1 General  
The concept of comfort is based on several different factors, such as physiological comfort, ease of movement 
or factors that will influence and/or affect the individual's satisf action with the product.  
Combinations of materials and design of clothing, notably scrub suits and operating theatre gowns that will 
minimize the physiological stress during work are to be encouraged.  
The thermophysiological comfort of a garment depends on  such properties as its thermal resistance, air 
permeability, water -vapour resistance and drapeability.  
Tactile comfort is highly dependent on properties of the fabric such as stretchability, drapeability and the 
surface structure of the fabric, and also o n garment weight, size, fit and manufacture.  
Other properties, such as rustling tendency, softness and skin irritation are difficult to measure. Evaluation 
should be based on trials of the products or practical experience.  
A.2 Surgical gowns and clean air suits  
The overall comfort of surgical gowns and clean air suits can be influenced by a number of factors: design, fit, 
breathability, weight, surface thickness, electrostatic properties, colour, light reflectance, odour and skin 
sensitivity.  
Other importan t variables that can influence comfort include undergarments, health and physical conditions, 
work load, mental stress and environmental conditions, such as temperature, relative humidity, and air 
changes in operation room.  
Comfort is subjective and can be  influenced by one or a combination of the aforementioned factors.  
A.3 Surgical drapes  
Surgical drapes should be flexible so that they will cover the patient closely and smoothly, allowing placement 
and manipulation of instruments and draping of other rela ted equipment, such as ring stands, back tables, and 
Mayo stands.  FDUS 966-1: 2011  
8 © UNBS 2011  – All rights reserved  
 Annex  B 
(informative)  
 
Adhesion for fixation and wound isolation  
Adhesives are used to attach fabrics during the preparation for an operation and to attach drapes to a patient 
on the operati ng table. Different adhesives are chosen for different materials, for example,  material to material 
and material to the skin.  
In choosing an adhesive, the following considerations should be taken into account:  
a) adhesives should not cause damage to the skin.  
b) when used on reusable materials, the adhesives should be removable during reprocessing without 
damaging the fabric.  
 FDUS 966-1: 2011  
© UNBS 2011  – All rights reserved  9 
 Annex  C 
(informative)  
 
Prevention infection in the operating theatre  
The majority of post -operative surgical site infections are acquired at the time of operation when there is a 
possibility for micro -organisms to reach the open wound. The source of micro -organisms is either exogenous, 
that is,  staff, inanimate objects, fellow patients or endogenous, that is,  the patient. In clean operations , that is,  
operations in sterile tissue and where hollow viscus is not entered the skin of operating room personnel and of 
the patient are the most important sources of micro -organisms. In infection -prone operations, for example,  
orthopaedic and vascular i mplant surgery, the normal microbial skin flora is of significance as a cause of 
surgical site infection.  
Routes of infection are contact or airborne. In the latter case, dispersed human skin scales are often the 
carriers of infection. Some of the types of  barrier used to reduce surgical site infection are addressed in this 
series of standards.  
A healthy individual can disperse to the air approximately 5000 bacteria -carrying skin scales per minute during 
walking. The particles are 5 μm to 60 μm in size and the average number of aerobic and anaerobic bacteria 
carried is estimated to be about five per skin scale. The airborne particles contaminate the wound directly by 
sedimentation or indirectly by first settling on instruments or other items that are then br ought into contact with 
the wound. Fabrics with interstices larger than 80 μm do little to prevent the dispersal of skin scales.  
Clean air suits can support the reduction of the dispersal of bacteria -carrying skin scales from the human body 
into the operat ing theatre air. Clean air suits should be used in addition to surgical gowns and not as a 
substitute.  
Surgical gowns are used to prevent direct contact transfer of infective agents from the surgical team to the 
operating wound and vice versa. Surgical gow ns prevent dispersal of skin scales to the operating theatre air 
only if they are made of a suitable material and used in combination with ultra -clean air systems.  
Drapes are used to provide a microbiologically clean working area around the wound. If they enclose the 
wound tightly and are fixed to the skin, they also reduce transfer of the patient's skin flora into the wound. 
Drapes and/or collective devices are also used to control the spread of potentially contaminated body fluids 
from the wound area.  FDUS 966-1: 2011  
10 © UNBS 2011  – All rights reserved  
 Bibliography  
[1] En 13795 -1, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical 
staff and equipments – part 1: General requirements for manufacturers, processors and products  
[2] ISO 9237, Textiles — Determination of the permeability of fabrics to air  
[3] ISO 11810, Optics and optical instruments — Lasers and laser -related equipment — Surgical drapes 
and patient protective covers suitable for use with lasers.  
[4] ISO 13485, Quality systems — Medical devices — Particula r require ments for the application of ISO 
9001  
[5] ISO 13488, Quality systems — Medical devices — Particular require ments for the application of ISO 
9002  
. FDUS 966-1: 2011  
© UNBS 2011 – All rights reserved  11 
 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 ma rk 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 stand ard 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 o f the terms and conditions of licensing may be obtained from the Director, Uganda 
National Bureau of Standards.  
 
 FDUS 966-1: 2011    
 
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