ICS 11.140  
 
Reference number
DRS 440: 2020
© RSB 2020
  
 RWANDA 
STANDARD  DRS 
440
First edition
2020 -mm-dd
Surgical clothing and drapes —
Specification  
 
   
DRS 440: 2020  
©RSB 2020 - All rights reserved                  ii 
 In order to match with technological development and to keep continuous progress in industries, 
standards are subject  to periodic review. Users shall ascertain that they are in possession of the latest 
edition  
 
 
 
 
 
 
 
 
© RSB2020  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or ut ilized 
in any form or by any means, electronic or mechanical, including photocopying and microfilm, without 
prior written permission from R SB. 
Requests for permission to reproduce this document should be addressed to : 
Rwanda Standards  Board  
P.O Box 7099 Kigali -Rwanda  
KK 15 Rd, 49  
Tel. +250 788303492  
Toll Free: 3250  
E-mail: info@rsb.gov.rw  
Website: www.rsb.gov.rw  
ePortal: www.portal.rsb.gov.rw  DRS 440: 2020  
iii                ©RSB 2020 - All rights reserved  
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ...................... iv 
1 Scope  ................................ ................................ ................................ ................................ ................ 1 
2 Normative references  ................................ ................................ ................................ ....................... 1 
3 Terms and definitions  ................................ ................................ ................................ ...................... 2 
4 Requirements  ................................ ................................ ................................ ................................ ...5 
4.1 General requirements ................................ ................................ ................................ ....................... 5 
4.2 Safety requirements  ................................ ................................ ................................ ......................... 6 
4.2.1  Biocompatibility  ................................ ................................ ................................ ............................... 6 
4.2.2  Sterility assurance level  ................................ ................................ ................................ ................... 6 
4.2.3  Flame spread  ................................ ................................ ................................ ................................ ....6 
4.2.4  Natural Rubber Latex  ................................ ................................ ................................ ....................... 6 
4.3 Performa nce requirements  ................................ ................................ ................................ .............. 6 
5 Packaging and labelling  ................................ ................................ ................................ ................... 8 
5.1 Packaging  ................................ ................................ ................................ ................................ ......... 8 
5.2 Product labelling  ................................ ................................ ................................ .............................. 8 
5.3 Package labelling  ................................ ................................ ................................ ............................. 9 
6 Sampling  ................................ ................................ ................................ ................................ ........... 9 
Annex  A (normative)  Testi ng ................................ ................................ ................................ .....................  10 
The following specific amendments to the procedures shall be considered:  ................................ .........  10 
A.1 Test method for evaluation of particle release  ................................ ................................ ..............  10 
A.2 Test method for evaluation of liquid penetration  ................................ ................................ ..........  10 
A.3 Test method for evaluation of dry and wet microbial penetration  ................................ ...............  10 
 DRS 440: 2020  
©RSB 2020 - All rights reserved                  iv 
 Foreword  
Rwanda Standard sareprepared by Technical Committees and approved by R wanda Standards Board (RSB) 
Board  of Directors in  accordance with the procedures of RSB, in compliance with Annex 3 of the WTO/TBT 
agreement on the preparation, adoption and application of standards.  
The main task of technical committees is to prepare national standards.  Final Draft Rwanda S tandards 
adop ted by Technical committ ees are ratified  by me mbers of RSB Board of Director s for publication and 
gazettment as Rwanda Standards.  
DRS 440 was prepared jointly by Technical Committee RSB/TC 029, Textile and Leather technology  and 
RSB/TC 034, Medical eq uipment and accessories devices.  
In the preparation of this standard, reference was made to the following standard s: 
1) EN 13795 -1:2019 , Surgical clothing and drapes — Requirements and test methods —Part 1: Surgical 
drapes and gowns  
2) EN 13795 -2:2019, Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits  
The assistance de rived from the above source is hereby acknowledged with thanks.  
Committee membership  
The following organizations were represented on the Technical Committee on Textile and Leather technology 
(RSB/TC 029) in the preparation of this standard.  
Ministry of Trade and Industry (MINICOM)  
University of Rwanda -College of Science and Technology (UR -CST)  
Centre Hospitalier Universitaire de Butare (CHUB)  
Centre Hospitalier Universitaire de Kigali (CHUK)  
Rwanda Military Hospital Rwanda Military Hospital (RMH)  
Rwanda Inspectorate, Competition and Consumer Protection Authority (RICA)  
Rwanda Biomedical Centre  (RBC)  
Rene Pharmacy  
UTEXRWA Ltd  DRS 440: 2020  
v                ©RSB 2020 - All rights reserved  
 GLO CREATIONS  
LIXIL/SATO  
Rwanda Standards Board (RSB) – Secretariat  
 
 DRS 440: 2020  
©RSB 2020 - All rights reserved                  vi 
 Introduction  
Surgical drapes, surgical gowns and clean air suits are used to minimize the spread of infective agents to and 
from patients’ operating wounds andprevention of dispersal of bacteria -carrying skin scales f rom the operating 
room staff  thereby helping to prevent post -operative wound infections.  
The performance required of coverings for patients, clinical staff and equipment varies with, for ex ample, the 
type and duration of the procedure, the degree of wetnes s of the operation field, the degree of mechanical 
stress on the materials and the susceptibility of the patient to infection.  Therefore, the requirements in this 
standard  are expected to be of help to manufacturers and users when designing, processing, as sessing and 
selecting products. It is the intention of this standard to ensure the same level of safety from sin gle-use and 
reusable surgical clothing and drapes throughout their useful life.  DRS 440: 2020  
1                ©RSB 2020 - All rights reserved  
 Surgical clothing and drapes –Specification  
1 Scope  
ThisDraft Rwanda Standard specifies the requirements, sampling and test methods for surgical drapes ,singl e-
use and reusable gowns ,clean air suits  and drapes used as medical consumables  for patients, clinical staff 
and equipment to prevent the transmission of infective agents between clinical staff and patients du ring 
surgical and other invasive procedures.  
This standard  does not cover requirements for resistance to penetration  by laser radiation of products and it  is 
not applicable to  incision drapes or films , isolation gowns and decontamination gowns . 
2 Normative references  
The following documents are referre d to in the text in such a way that some or all of their content constitutes 
requirements of this document.  For dated references, only the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendment s) applies.  
RS ISO 139, Textiles — Standard atmospheres for conditioning and testing  
ISO 2859 -1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by 
acceptance quality limit (AQL) for lot -by-lot inspection  
ISO 9073 -10, Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry 
state  
ISO 9073 -18, Textiles — Test methods for nonwovens — Part 18: Determination of breaking strength and 
elongation of nonwoven materials using the grab tensile test  
ISO 10993 -1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk 
management process  
ISO 10993 -10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization  
ISO 11737 -1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a 
population of microorganisms on products  
ISO 12952 -2, Textiles — Assessment of the ignitability of bedding items — Part 2: Ignition source: match -
flame equivalent  
RS ISO 13688 , Protective clothing — General requirements  
ISO 13938 -1, Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting 
strength and bursting distension   
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 ISO 22610, Surgical drapes, gowns and clean air suits, us ed as medical devices, for patients, clinical staff and 
equipment - Test method to determine the resistance to wet bacterial penetration  
ISO 22612, Clothing for protection against infectious agents - Test method for resistance to dry microbial 
penetration  
3 Terms and definitions  
For the purposes of this standard, the terms and definitions given in RS 433 -1 and the following apply.  
3.1 
critical product area  
product area with a greater probability to be involved in the transfer of infective agents to or fro m thewound, 
e.g. front and sleeves of surgical gowns  
3.2 
infective agent  
micro -organism that has been shown to cause wound infections or that might cause infection in amember of 
the surgical team or the patient  
3.3 
less critical product area  
product area less  likely to be involved in the transfer of infective agents to or from the wound  
3.4 
particle release  
release of fibre fragments and other particles during mechanical stress simulating handling and use  
3.5 
performance level  
discrete standard defined to classify products according to the performance requirements of thisdocument  
Note 1 to entry: With the introduction of two performance levels, this document acknowledges the fac t 
thatproducts are challenged to differing extents during surgical procedures, d ependent upon the duration, 
mechanicalstress and liquid challenge throughout the surgical procedure.  DRS 440: 2020  
3                ©RSB 2020 - All rights reserved  
 3.5.1  
standard performance  
classification addressing minimum performance requirements for various characteristics of productsus ed as 
medical devices in inv asive surgical procedures  
3.5.2  
high performance  
classification addressing elevated performance requirements for various characteristics of productsu sed as 
medical devices in invasive surgical procedures  
NOTE  Examples of surgical procedures where elevated performance level should be considered arethose where 
extensive exposure to liquid, mechanical stresses or longer surgical procedures can be expected.  
3.6 
processor  
natural or legal person who processes products so that their performance complies with ther equirements of 
this standard  
NOTE 1 A processor who places a product on the market is a manufacturer in the sense of thisdocument.  
NOTE 2  A processor of reusable products is often referred to as a ‘reprocessor’ and processing reusableprod ucts is 
often re ferred to as ‘reprocessing’ (as e.g. in Medical Device Directive 93/42/EEC).  
3.7 
resistance to liquid penetration  
ability of material to withstand the penetration of liquid(s) from one side of the material to an other  
3.8 
resistance to microbial penetration  
ability of material(s) to withstand penetration of micro -organisms from one side of the material through to the 
other  
3.8.1  
dry penetration  
effect of a combination of air movement and mechanical action by vibration on microbial penetration in dry 
condition   
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 3.8.2  
wet penetration  
effect of combination of wetness, pressure and rubbing on microbial penetration  
3.9 
reusable product  
product intended by the manufacturer to be reprocessed and reused  
3.10 
single -use product  
product intended to be used once only for a single patient  
3.11 
sterile field  
area created by sterile surgical drape material where aseptic technique is practised  
Note 1 to entry: A sterile field can be practised e.g. on a back table.  
3.12 
surgical drape  
drape covering the patient or  equipment to prevent transfer of infective agents  
3.13 
surgical gown  
gown intended to be worn by operating room personnel during surgical procedures to protect both the surgi cal 
patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate 
matter.  
3.14 
surgical clean air suit  
suit, used as working garment, intended and shown to minimize contamination of the operating room ai r from 
skin scales originating on the skin of persons wearing it  
NOTE 1 A scrub suit is a working garment for operating room staff that does not need to meet the requirements for a 
clean air suit. The scrub suit is not primarily intended to prevent airborne dispersal from staff, a nd can be designed and 
processed as the manufacturer thinks fit.  
NOTE  2  A clean air suit consists of a coverall, or a blouse and trousers.  DRS 440: 2020  
5                ©RSB 2020 - All rights reserved  
 3.15 
surgical procedure  
surgical intervention performed by a surgical team  
 
3.15.1 
invasive surgical procedure  
surgical procedure penetrating skin or mucosa  
3.16 
product  
clean air suit , surgical gown or surgical drape including equipment covering  
3.17 
critical zone(s),  
area of a gown where direct contact with blood, body fluids, and other potentially infectious materi als is most 
likely to occur.  
4 Requirements  
4.1 General requ irements  
4.1.1  Surgical drapes and gowns shall comply with the general require ments described in RS ISO 13688 
and a quality system such as ISO 13485 . 
4.1.2  Surgical gowns shall comply with the following additional general requirements:  
a) If present on surgical gowns, the neckline closure shall close easily and properly in donning, stay secure 
during wearing and open easily for removal.  
b) The surgical gown  shall be constructed with appropriate amount of stitching and construction adhesive so 
that the gown can be opened up freely and easily donned.  
c) The surgical gown s hall have no visible tears, cuts, holes, excessive stains or excessive patches.  
d) The surgical gown  shall contain no visible foreign matter such as dirt, grease, extraneous fabric or  thread 
on the surface of the gown or folded into the gown.  
  
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 4.1.3  Clean air suits  shall comply with the following additional general requirements:  
In order to manufacture a functioning clean air suit, design shall also be considered. When the mate rial of  the 
clean air suit is tight, bacteria are dispersed through the openings for head, arms and feet. Arm an d feet 
openi ngs shall therefore be closed and a barrier hood shall  be worn, tucked into the gap at the neckline. If the 
clean air suit consists of blou se and trousers, the blouse should be tucked into the trousers or designed with a 
tightly fitting waist.  
4.2 Safety requirements  
4.2.1  Biocompatibility  
Materials used in the construction of surgical gowns , clean air suits and drapes shall be classified as external 
devices that contact breached or compromised surfaces for limited exposures and shall pass theappropr iate 
evaluations in accordance  withISO 10993 -5 for cytotoxicity and ISO 10993 -10 for sensitivity.  
4.2.2  Sterility assurance level  
4.2.2.1  The selected sterilization process for surgical gown ,clean air suits and drapes s shall have a sterility 
assurance level of at least 10 -6. Appropriate sterilization processes include those specified in ISO 11134 for moist heat, 
ISO 11135 for EtO, ISO 11137 for Gamma or  ISO 13683 also for moist heat.  
4.2.2.2  The manufacturing facility shall be sterilized  
4.2.3  Flame spread  
Materials used in the construction of surgical gowns , clean air suits and drapes  shall meet the requirements 
for Class 1 “normal flammability” in accordanc e with ISO 12952 -2. 
4.2.4  Natural Rubber Latex  
Gowns that contain natural rubber latex shall include the latex caution statement “ This product contains 
natural rubber latex which may cause allergic reaction.”  
4.3 Performance requirements  
4.3.1  Surgical gowns , drapes and clean air suits shall comply with  the performance requireme nts of Tables 
1,2and 3, respectively , when tested in accordance with the test methods specified therein,  throughout their 
useful life.  
4.3.2  Samples shall be conditioned in accordance wi th RSISO 139.  
Table 1 — Characteristics to be evaluated and performance requirements for surgical gowns  
Characteristic  Requirement  Test method  
Standard performance  High performance  
Critical 
product area  Less critical 
product area  Critical 
product area  Less critical 
product area  DRS 440: 2020  
7                ©RSB 2020 - All rights reserved  
 Microbial penetration –Dry,  CFU , 
max Not required  300 a Not required   300 a ISO 22612  
Microbial penetration — Wet, I B ≥ 2,8 b Not required  6,0 b ,c 
 Not required  
 ISO 22610  
Cleanliness microbial /Bioburden, 
CFU/100 cm2, max  300 300 300 300 
 ISO 11737 -1 
Particle release, log 10 (lintcount) , 
max 4,0 4,0 4,0 4,0 ISO 9073 -10 
Liquid penetration, cm H 2O, min  20 10 100 10 ISO 811  
 
Total heat loss,  W/m², min  450 ASTM F1868  
Bursting strength —Dry, kPa , min  40 40 40 40 ISO 13938 -1 
Bursting strength —Wet, kPa , 
min 40 Not required  40 Not required  
 ISO 13938 -1 
Tensile strength — Dry, N , min  20 20 20 20 ISO 9073 -18 
Tensile strength —Wet, N , min  20 Not required  20 Not required  
 ISO 9073 -18 
a Test conditions: challenge concentration 108 CFU/g talcum and 30 min vibration time.  
b The Least Significant Difference (LSD) for IB whe n estimated using  ISO 22610, was found to be 0,98 at the 95 % confidence level. This 
is the minimum difference needed to distinguish between two materials thought to be different. Thus materials varying by up t o 0,98 IB 
are probably not different; materials varying by more  than 0,98 IB probably are different. (The 95 % confidence levels means that an 
observer would be correct 19 times out of 20 to accept these alternatives.)  
c IB = 6,0 for the purpose of this document means: no penetration. IB = 6,0 is the maximum achievabl e value.  
 
Table 2 — Characteristics to be evaluated and performance requirements for surgical drapes  
Characteristic  Requirement  Test method  
Standard performance  High performance  
Critical product 
area Less critical 
product area  Critical 
product 
area Less critical 
product area  
 Microbial penetration –Dry, CFU , 
max Not required  ≤ 300 a Not 
required  ≤ 300 a ISO 22612  
Microbial penetration — Wet, I B ≥ 2,8 b Not required  6,0 b, c 
 Not required  
 ISO 22610  
Cleanliness microbial /Bioburden, 
CFU/100 cm2, max  300 300  300  300 
 ISO 11737 -1 
Particle release, log 10(lint count) , 
max 4,0  4,0  4,0  4,0 ISO 9073 -10 
Liquid penetration hydrostatic head 
test’ or , cm H 2O, min   20 10  100  10 ISO 811  
Bursting strength —Dry, kPa , min   40  40  40  40 ISO 13938 -1 
Bursting strength —Wet, kPa , min  40 Not required  40 Not required  
 ISO 13938 -1  
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 Tensile strength — Dry, N , min   15 15  20  20 ISO 9073 -18 
Tensile strength —Wet, N , min  15 Not required   20 Not required  
 ISO 9073 -18 
a Test conditions: challenge concentration 108 CFU/g talcum and 30 min vibration time.  
bThe Least Significant Difference (LSD) for IB whe n estimated using  ISO 22610, was found to be 0,98 at the 95 % confidence level. This is the 
minimum difference needed t o distinguish between two materials thought to be different. Thus materials varying by up to 0,98 IB  are probably 
not different; materials varying by more than 0,98 IB probably are different. (The 95 % confidence l evel means that an observ er would be 
corre ct 19 times out of 20 to accept these alternatives.)  
c IB = 6,0 for the purpose of this document means: no penetration. I B = 6,0 is the maximum achievable value.  
 
Table 3 — Performance requirements for clean air suits  
Characteristic  
 Requirement  Test method  
Standard performance  
 High performance  
Microbial penetration -Dry,  CFU , max  100a 50a ISO 22612  
Cleanliness microbial /  
Bioburden, CFU/100 cm2, max  100 100 ISO 11737 -1 
Particle release, log 10 (lint count) , max  4,0 4,0 ISO 9073 -10 
Bursting strength —Dry, kPa , min  40 40 ISO 13938 -1 
Tensile strength — Dry,  N , min  20 20 ISO 9073 -18 
a Test conditions: challenge concentration 108 CFU/g talcum and 30 min vibration time  
 
4.3.2 If the manufacturer does not differentiate product areas, all areas shall meet the requirements for 
critical product areas.  
4.3.4 For general information on testing and details on the test methods  given in this clause including 
Tables 1 and 2 and their application for the purpose of this document, see Annex A.  
5  Packaging a nd labelling  
5.1 Packaging  
5.1.1  Surgical gowns , clean air suits  and drapes  shall be packaged in a suitable environmental -friendly 
packaging material to prevent damage  and contamination  during storage and transportation.   
5.1.2  Only surgical gowns , clean air suits and drapes  of the same size shall be packed together in both 
primary and secondary packages  
5.2 Product l abelling  
Each surgical gown, clean air suits  or drape item shall be legibly and indelibly labelled with the following 
information:  DRS 440: 2020  
9                ©RSB 2020 - All rights reserved  
 a) manufa cturer name and addres s; 
b) product name;  
c)  barrier performance level for the surgical gown ; 
d)  product lot or serial number;  
e) size; and  
f) product intended use.  
g) For multiple -use products, processing instructions, including a statement of the number of times that the 
product can be processed and continue to maintain its safety and performance characteristics.  
5.3 Package l abelling  
5.3.1  Each package containing surgical gowns , clean air suits  or drapes  shall be labelled with the same 
information as required in 5.2  
5.3.2  The following additional information shall be provided on the packaging labelling.  
a) If the gown contains natural rubber latex, it must be labelled with a caution statement as per 4.2.4.  If the 
gown and its components are composed of materials that are  free from natural rubber latex, it is optional 
for this information to be on a label.  
b) surgical gowns which are intended for reuse shall have affixed or attached a means for marking or 
recording the number of laundering and sterilization cycles to which the specific item has been subjected.  
c) instructions for storage, use, cleaning, maintenance, servicing and disinfection  
d) where applicable, the month and year or period of obsolescence of the surgical clothing  or of certain of its 
components;  
6 Sampling  
The sam pling shall be done in accordance with RS ISO 2859 -1  
©RSB 2020 - All rights reserved                  10 
 Annex  A 
(normative)  
 
Testing  
The following specific amendments to the procedures shall be considered : 
A.1 Test method for evaluation of particle release  
As specified in ISO 9073 -10, ten specimens, five for each sid e of the material, shall be tested. The result of 
the test, i.e. the coefficient of linting, shall be calculated for particles in the size range 3 µm to 25 µm and 
reported as log 10 of the count value.  
NOTE  Particles of this size range are considered to be capable of carrying microorganisms.  
A.2 Test method for evaluation of liquid penetration  
For evaluation of liquid penetration, the product shall be tested according to ISO 811.  
The following specific amendments to the procedure in ISO 811 apply for the purp ose of this standard: 
a) the test area shall be 100 cm2; 
b) the rate of increase of water pressure shall be (10 ± 0,5) cm/min;  
c) the temperature of the water shall be (20 ± 2) °C; and  
d) the side of the product in contact with the test liquid shall be the outer side.  
Five specimens shall be tested.   
A.3 Test method for evaluation of dry and wet microbial penetration  
For evaluation of dry microbial penetration, the product  shall be tested according to  ISO 22612.  
If both sides of the material to be tested are different, the side intended to cover the contamination source 
during medical use as stated by the manufacturer shall be exposed to the inoculated donor in the tes t. 
NOTE  The side intended to cover the contamination source during medical use is, e.g. the inner side of a surgical 
gown or the patient or equipment side of a surgical drape.  
If the product has an antimicrobial treatment, it shall be mentioned in the test report since it can  influence the 
results.  DRS 440: 2020  
11                ©RSB 2020 - All rights reserved  
 Bibliography  
[1] EN 1041, Information supplied by the manufactu rer of medical devices  
[2]  EN 14065, Textiles - Laundry processed textiles - Biocontamination control system  
[3]  EN 62366, Medical devices - Application of usability engineering to medical devices  
[4] ISO 9073 -6, Textiles - Test methods for nonwovens - Part 6: Absor ption  
[5] ISO 9073 -11, Textiles - Test methods for nonwovens - Part 11: Run -off  
[6] ISO 9073 -12, Textiles - Test methods for nonwovens - Part 12: Demand absorbency  
[7] ISO 9237, Textiles - Determination of permeability of fabrics to air  
[8] ISO 10993 -5, Biological eval uation of medical devices - Part 5: Tests for in vitro cytotoxicity  
[9] ISO 10993 -10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin 
sensitization  
[10] ISO 11092, Textiles - Physiological effects - Measurement of thermal and wate r-vapour resistance 
under steady -state conditions (sweating guarded -hotplate test  
[11] ISO 11607 -1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, 
sterile barrier systems and packaging  
[12] ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes  DRS 440: 2020  
 
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