Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.

Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-Kleidung

Diese Europäische Norm legt die Informationen fest, die dem Anwender und Prüfer (Dritte) zu liefern sind, zusätzlich zu der normalen Kennzeichnung von Medizinprodukten (siehe EN 1041 und EN ISO 15223 1) bezüglich Anforderungen an die Herstellung und Aufbereitung. Diese Europäische Norm gibt Aufschluss über die Eigenschaften von Einmal  und Mehrweg Rein Luft Kleidung zur Verwendung als Medizinprodukte für Klinikpersonal, zum Schutz vor Übertragung infektiöser Agenzien zwischen Klinikpersonal und Patienten während operativer und anderer invasiver Eingriffe. Diese Europäische Norm legt Prüfverfahren zur Bewertung der bestimmten Eigenschaften von Rein Luft Kleidung sowie die Anforderungen an diese Produkte fest.

Vêtements et champs chirurgicaux - Exigences et méthodes d’essai - Partie 2 : Tenues de bloc

La présente Norme européenne spécifie les informations à fournir aux utilisateurs et aux vérificateurs tiers en plus de l’étiquetage usuel des dispositifs médicaux (voir l’EN 1041 et l’EN ISO 15223-1) concernant les exigences de fabrication et de traitement. La présente norme européenne fournit des informations sur les caractéristiques des tenues de bloc, qu’elles soient à usage unique ou réutilisables, utilisées en tant que dispositifs médicaux pour le personnel médical et destinées à empêcher la transmission d’agents infectieux entre le personnel chirurgical et les patients au cours des interventions chirurgicales et autres interventions invasives. La présente Norme européenne spécifie les méthodes d’essai permettant d’évaluer les caractéristiques identifiées des tenues de bloc et établit les exigences de performance pour ces produits.

Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 2. del: Čista oblačila

Ta evropski standard določa informacije, ki jih je treba poleg običajnega označevanja medicinskih pripomočkov (glej standarda EN 1041 in EN ISO 15223-1) podati uporabnikom in tretjim strankam, ki izvajajo preverjanje, in sicer v zvezi z zahtevami za proizvodnjo in obdelovanje. Ta evropski standard podaja informacije o lastnostih čistih oblačil za enkratno in večkratno uporabo, ki se uporabljajo kot medicinski pripomočki za zdravstveno osebje ter so namenjeni za preprečevanje prenosa infekcijskih agentov med zdravstvenim osebjem in pacienti med kirurškimi in drugimi invazivnimi postopki. Ta evropski standard določa preskusne metode za ocenjevanje identificiranih lastnosti čistih oblačil in določa zahteve glede zmogljivosti teh proizvodov.

General Information

Status
Published
Publication Date
02-Apr-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
03-Apr-2019
Completion Date
03-Apr-2019

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SLOVENSKI STANDARD
SIST EN 13795-2:2019
01-julij-2019
Nadomešča:
SIST EN 13795:2011+A1:2013
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 2. del: Čista
oblačila

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 2: Rein-

Luft-Kleidung

Vêtements et champs chirurgicaux - Exigences et méthodes d’essai - Partie 2 : Tenues

de bloc
Ta slovenski standard je istoveten z: EN 13795-2:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 13795-2:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 13795-2:2019
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SIST EN 13795-2:2019
EN 13795-2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2019
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 13795:2011+A1:2013
English Version
Surgical clothing and drapes - Requirements and test
methods - Part 2: Clean air suits

Vêtements et champs chirurgicaux - Exigences et Operationsbekleidung und -abdecktücher -

méthodes d'essai - Partie 2 : Tenues de bloc Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-

Kleidung
This European Standard was approved by CEN on 24 October 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13795-2:2019 E

worldwide for CEN national Members.
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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 6

1 Scope .................................................................................................................................................................... 7

2 Normative references .................................................................................................................................... 7

3 Terms and definitions ................................................................................................................................... 7

4 Performance requirements ...................................................................................................................... 10

5 Manufacturing and processing requirements and documentation ........................................... 11

6 Information to be supplied with the product .................................................................................... 11

6.1 Information to be supplied to the user ................................................................................................ 11

6.2 Information to be supplied to the processor ..................................................................................... 11

Annex A (normative) Testing ................................................................................................................................ 12

A.1 General ............................................................................................................................................................. 12

A.2 Test methods and conformance .............................................................................................................. 12

A.2.1 Test method for evaluation of cleanliness microbial/bioburden .............................................. 12

A.2.2 Test method for evaluation of particle release ................................................................................. 12

A.2.3 Test method for evaluation of bursting strength in dry state ...................................................... 13

A.2.4 Test method for evaluation of tensile strength in dry state ......................................................... 13

A.2.5 Test method for evaluation of dry microbial penetration ............................................................ 13

A.2.6 Test method for evaluation of biocompatibility ............................................................................... 13

A.3 Treatment of results ................................................................................................................................... 13

Annex B (informative) Rationales ....................................................................................................................... 15

B.1 General ............................................................................................................................................................. 15

B.2 Cleanliness – microbial .............................................................................................................................. 15

B.3 Particle release ............................................................................................................................................. 15

B.4 Bursting strength – dry .............................................................................................................................. 16

B.5 Tensile strength – dry ................................................................................................................................. 16

B.6 Resistance to microbial penetration – dry .......................................................................................... 16

B.7 Labelling .......................................................................................................................................................... 17

B.8 Treatment of results ................................................................................................................................... 17

B.9 Flammability .................................................................................................................................................. 18

B.10 Electrostatic discharge ............................................................................................................................... 18

Annex C (informative) Environmental aspects ............................................................................................... 19

Annex D (informative) Guidance to users for selecting products ............................................................ 20

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SIST EN 13795-2:2019
EN 13795-2:2019 (E)

D.1 General ............................................................................................................................................................. 20

D.2 Performance levels ...................................................................................................................................... 20

D.3 Functional design aspects .......................................................................................................................... 20

D.3.1 Size ..................................................................................................................................................................... 20

D.3.2 Accessories ...................................................................................................................................................... 20

D.4 Comfort ............................................................................................................................................................. 21

D.4.1 General ............................................................................................................................................................. 21

D.4.2 Clean air suits ................................................................................................................................................. 21

D.4.3 Practical trials ................................................................................................................................................ 21

Annex E (informative) Functional design ......................................................................................................... 22

E.1 General ............................................................................................................................................................. 22

E.2 Test method for measuring source strength ...................................................................................... 22

E.2.1 Dispersal chamber ....................................................................................................................................... 22

E.2.2 Operating room ............................................................................................................................................. 23

E.2.3 Measuring bacteria carrying airborne particles ............................................................................... 23

E.2.4 Source strength ............................................................................................................................................. 23

E.3 Use of source strength measurements .................................................................................................. 24

Annex ZA (informative) Relationship between this European standard and the essential

requirements of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered ........................ 26

Bibliography ................................................................................................................................................................. 27

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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
European foreword

This document (EN 13795-2:2019) has been prepared by Technical Committee CEN/TC 205 “Non-

active medical devices”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by October 2019, and conflicting national standards shall

be withdrawn at the latest by October 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

Together with EN 13795-1:2019, this document supersedes EN 13795:2011+A1:2013.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this

document.

EN 13795 consists of the following parts, under the general title Surgical clothing and drapes —

Requirements and test methods:
— Part 1: Surgical drapes and gowns
— Part 2: Clean air suits
The following changes have been introduced:

a) Restriction to the product ‘clean-air suit’ in this Part of the EN 13795 standard series (for surgical

drapes and gowns see EN 13795-1);
b) Alignment of the Standard title and the Scope;
c) Revision of the Normative references and the Bibliography;
d) Alignment of the Clause ‘Terms and definitions’;
e) Revision of the performance requirements in Table 1;
f) Movement of former Clause 5 ‘Testing’ to A.1 and editorial alignment;

g) Revision of Clause ‘Manufacturing and processing requirements‘ by adding of documentary

requirements and a section for the introduction of a QM system;

h) Enhancement and improved structuring of Clause ‘Information to be supplied by the manufacturer

or processor’;

i) Deletion of the former Annex A ‘Details of significant changes between this document and the

previous edition’;

j) Complete revision and extension of Annex A ‘Testing’ (formerly Annex B ‘Test methods’);

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SIST EN 13795-2:2019
EN 13795-2:2019 (E)

k) Inclusion of a new Annex B ‘Rationales’ which provides precise reasons for the essential

requirements of this document and which is intended for users aware of the subject of this

document, but who did not join whose development;

l) Deletion of the former Annex C ‘Prevention of infection in the operating room‘;

m) Inclusion of a new Annex C ‘Environmental aspects’;
n) Inclusion of a new Annex D ‘Guidance to users for selecting products‘;
o) Inclusion of a new Annex E 'Functional design';

p) Revision of Annex ZA on the relationship to the Medical Device Directive (93/42/EEC);

q) Complete editorial revision.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
Introduction

Clean air suits are used to minimize the spread of infective agents to patients’ surgical sites and

equipment, through prevention of dispersal of bacteria-carrying skin scales from the operating room

staff, thereby helping to prevent post-operative surgical site infections.

The performance required of working clothes for clinical staff varies with, for example, the type and

duration of the procedure, and the susceptibility of the patient to infection. In infection-prone invasive

operations, a clean air suit can contribute to reduction of infection risks, in conjunction with ventilation

and correct working methods.

This document is intended to assist the communication between manufacturers and third parties with

regard to material or product characteristics and performance requirements.

Therefore, Annex B provides comprehensive information on characteristics, measurement of

performance and performance requirements. Annex C clarifies that this document does not include

environmental provisions. Annex D explains the concept of performance levels and provides guidance

to users for selecting products. Annex E gives information on the impact of the design of clean air suits

and the source strength concept as an evaluation means for the impact of the entire clothing (including

clean air suits) on particle release.

This document focuses on Essential Requirements arising from the Medical Device Directive

93/42/EEC, which are applicable to clean air suits. The requirements and guidance in this document

are expected to be of help to manufacturers and users when designing, processing, assessing and

selecting products. It is the intention of this document to ensure the same level of safety from single-use

and reusable clean air suits throughout their useful life.
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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
1 Scope

This document specifies information to be supplied to users and third party verifiers in addition to the

usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and

processing requirements.

This document gives information on the characteristics of single-use and reusable clean air suits used as

medical devices for clinical staff, intended to prevent the transmission of infective agents between

clinical staff and patients during surgical and other invasive procedures.

This document specifies test methods for evaluating the identified characteristics of clean air suits and

sets performance requirements for these products.
2 Normative references

The following documents are referred 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 amendments) applies.

EN 29073-3:1992, Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and

elongation

EN ISO 139:2005, Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005 +

Amd. 1:2011)

EN ISO 9073-10:2004, Textiles - Test methods for nonwovens - Part 10: Lint and other particles

generation in the dry state (ISO 9073-10:2003)

EN ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a

risk management process (ISO 10993-1:2009)

EN ISO 11737-1:2018, Sterilization of medical devices — Microbiological methods — Part 1:

Determination of a population of microorganisms on products (ISO 11737-1:2018)

EN ISO 13938-1:1999, Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for

determination of bursting strength and bursting distension (ISO 13938-1:1999)

EN ISO 22612:2005, Clothing for protection against infectious agents - Test method for resistance to dry

microbial penetration (ISO 22612:2005)
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:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
Impacted by EN ISO 139:2005+A1:2011
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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
3.1
colony forming unit
CFU
unit by which the culturable number of microorganisms is expressed

Note 1 to entry: The culturable number is the number of microorganisms, single cells or aggregates, able to

form colonies on a solid nutrient medium.
3.2
clean air suit

suit, used as working garment, intended and shown to minimize contamination of the operating room

air from skin scales originating on the skin of persons wearing it

Note 1 to entry: 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,

and can be designed and processed as the manufacturer thinks fit.

Note 2 to entry: A clean air suit consists of a coverall, or a blouse and trousers.

3.3
cleanliness
freedom from unwanted foreign matter

Note 1 to entry: Such matter can be microorganisms, organic residues or particulate matter.

3.3.1
cleanliness — microbial
freedom from population of viable micro-organisms on a product and/or a package

Note 1 to entry: In practical use, microbial cleanliness is often referred to as ‘bioburden’.

3.4
infective agent

microorganism that has been shown to cause wound infections or that might cause infection in a

member of the surgical team or the patient
3.5
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 out by that person himself or on his behalf by a third party

Note 1 to entry: For more details refer to the Medical Device Directive 93/42/EEC.

3.6
particle release

release of fibre fragments and other particles during mechanical stress simulating handling and use

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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
3.7
performance level

discrete standard defined to classify products according to the performance requirements of this

document

Note 1 to entry: With the introduction of two performance levels this document acknowledges the fact that

products are challenged to differing extents during surgical procedures, dependent upon the microbial cleanliness

of the operating room required for the procedure.
3.7.1
standard performance

classification addressing minimum performance requirements for various characteristics of products

used as medical devices in invasive surgical procedures
3.7.2
high performance

classification addressing elevated performance requirements for various characteristics of products

used as medical devices in invasive surgical procedures

Note 1 to entry: Examples of surgical procedures where high performance level might be considered are

infection prone clean surgical procedures where air counts in the operating room of ≤ 10 CFU/m are required.

3.8
processor

natural or legal person who processes products so that their performance complies with the

requirements of this document

Note 1 to entry: A processor who places a product on the market is a manufacturer in the sense of this

document.

Note 2 to entry: A processor of reusable products is often referred to as a ‘reprocessor’ and processing reusable

products is often referred to as ‘reprocessing’ (as e.g. in Medical Device Directive 93/42/EEC). References in

EN 13795-1 and this document to ‘processors’ include ‘reprocessors’ and to ‘processing’ include ‘reprocessing’.

3.9
product
clean air suit
3.10
resistance to microbial penetration

ability of material(s) to withstand penetration of micro-organisms from one side of the material

through to the other
3.10.1
dry penetration

effect of a combination of air movement and mechanical action by vibration on microbial penetration in

dry condition
3.11
reusable product
product intended by the manufacturer to be reprocessed and reused
3.12
single-use product
product intended to be used once only for a single patient
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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
3.13
source strength

average number of bacteria-carrying particles (CFU) emitted per second from a person wearing a

specified garment during a certain activity in a specified environment
3.14
surgical procedure
surgical intervention performed by a surgical team
3.14.1
invasive surgical procedure
surgical procedure penetrating skin or mucosa
4 Performance requirements

To comply with this document, products shall meet all the requirements specified in this document

including Table 1, when tested according to Annex A of this document throughout their useful life.

The biocompatibility of the product has to be evaluated and approved for acceptable risk in accordance

with EN ISO 10993-1.

For general information on testing and details on the test methods given in this clause including Table 1

and their application for the purpose of this document, see Annex A.

NOTE Information on characteristics, which cannot be properly evaluated or which are not regarded

normative (as e.g. ‘comfort’) is given in Annexes B, D and E.

Table 1 — Characteristics to be evaluated and performance requirements for clean air suits

Requirement
Test method
(for normative
Characteristic Unit
Standard performance High performance
references see
Clause 2)
Microbial penetration
a a
EN ISO 22612 CFU
≤ 100 ≤ 50
— Dry
CFU/
Cleanliness microbial /
EN ISO 11737-1 ≤ 100 ≤ 100
Bioburden
100 cm
log
Particle release EN ISO 9073-10 ≤ 4,0 ≤ 4,0
(lint
count)
Bursting strength —
EN ISO 13938-1 kPa ≥ 40 ≥ 40
Dry
Tensile strength — Dry EN 29073-3 N ≥ 20 ≥ 20
a 8

Test conditions: challenge concentration 10 CFU/g talcum and 30 min vibration time.

The test methods given in Table 1 are materials tests. In order to manufacture a functioning clean air

suit, design shall also be considered. When the material of the clean air suit is tight, bacteria are

dispersed through the openings for head, arms and feet. Arm and feet openings shall therefore be

closed. A barrier hood should be worn, tucked into the gap at the neckline (see Annex E, E.1). If the

clean air suit consists of blouse and trousers, the blouse should be tucked into the trousers or designed

with a tightly fitting waist.
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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
5 Manufacturing and processing requirements and documentation

5.1 The manufacturer and processor shall document that the requirements of this document are met

and that the fitness for the intended purpose has been established for each use, both for single-use and

reusable medical devices.

5.2 The manufacturer/processor shall establish, document, implement and maintain a formal quality

management system, which includes risk management and maintain its effectiveness. This quality

management system shall include requirements throughout product realization, including

development, design, manufacture, testing, packaging, labelling, distribution and, for reusable products,

processing and life-cycle control.
Inputs for product realization shall include the outputs from risk management.

A quality system such as EN ISO 13485 is recommended, in case of processing of reusable products

applied in accordance with EN 14065.

For testing processes, quantitative physical, chemical and/or biological tests are preferred.

5.3 A clinical evaluation for clean air suits shall be carried out and shall consider the performance of

the clothing system to establish fitness for purpose. The evaluation shall include the critical review of

the applicable clinical literature and the results of post market surveillance and vigilance.

6 Information to be supplied with the product
6.1 Information to be supplied to the user
6.1.1 The following information shall be supplied on request:
a) the identity or information on the test methods used;

b) the results of testing and test conditions for the characteristics given in Clause 4.

6.1.2 The manufacturer shall inform the user of residual risks due to any shortcomings of the

protection measures adopted.

6.1.3 The manufacturer shall provide sufficient information about intended use of the product or

product system when conducting a surgical procedure. This shall include information on the

performance level of the product.
6.2 Information to be supplied to the processor

For reusable products the manufacturer shall obtain information to be supplied to the processor on the

number of reuses based on standardized processes, together with information on measures for

maintaining the technical and functional safety of the medical device and packaging.

NOTE EN ISO 15797, though dealing with workwear and personal protective equipment (PPE), can be useful

in developing standardized methods for reusable surgical textiles since it contains information on the principles

and equipment for simulated industrial laundering.
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SIST EN 13795-2:2019
EN 13795-2:2019 (E)
Annex A
(normative)
Testing
A.1 General

A.1.1 Testing for evaluation of the performance of products shall be done according to the test

methods specified in A.2. All test results and test conditions shall be recorded and retained.

A.1.2 Testing shall be performed on the finished product. Testing shall include potential weak spots.

NOTE 1 Performance requirements can vary in relation to the risk of transfer of infective agents to or from the

wound and the sterile field, and in relation to the ventilation flow of the room.

NOTE 2 To ensure product performance, combinations of materials or products in systems can be used.

A.1.3 During manufacture and processing, testing shall be conducted according to the requirements of

the manufacturer's and processor's quality system.

A.1.4 Alternative test methods for monitoring may be used provided that they are validated and

address the same characteristic and that the results have been shown to correlate with the test methods

given in this document.

A.1.5 Where the test methods of this document do not specify the atmosphere for pre-conditioning,

conditioning and testing, the specifications of EN ISO 139 shall be applied. Prior to testing, the samples

shall be conditioned in the relaxed state.
A.2 Test methods and conformance
A.2.1 Test method for evaluation of cleanliness microbial/bioburden

For evaluation of cleanliness — microbial, the product shall be tested according to EN ISO 11737-1.

NOTE EN ISO 11737-1 does not provide a fixed test method but
...

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