EN ISO 21322:2021
(Main)Cosmetics - Microbiology - Testing of impregnated or coated wipes and masks (ISO 21322:2020)
Cosmetics - Microbiology - Testing of impregnated or coated wipes and masks (ISO 21322:2020)
This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.
Kosmetische Mittel - Mikrobiologie - Prüfung von getränkten oder beschichteten Reinigungstüchern und Masken (ISO 21322:2020)
Dieses Dokument enthält eine Anleitung für die Auszählung und/oder zum Nachweis von Mikroorganismen, die in kosmetischen Mitteln vorhanden sind, die sich auf einem damit getränkten oder beschichteten Träger befinden (z. B. Reinigungstücher und Masken), wenn die Probenahme und der mikrobiologische Einfluss des hergestellten Produktes im Hinblick auf die mikrobiologische Probenahme und Prüfung eine besondere Herausforderung darstellen.
Der Grundsatz dieses Dokumentes kann auch auf ähnliche Produkte (z. B. Kissen, getränkte Schwämme usw.) oder Applikatoren (z. B. Pinsel, Quasten, Schwämme usw.) angewendet werden, ggf. mit einer Veränderung des Verfahrens.
Cosmétiques - Microbiologie - Essais sur lingettes et masques imprégnés ou enduits (ISO 21322:2020)
Le présent document fournit des recommandations pour le dénombrement et/ou la détection des micro-organismes présents dans les produits cosmétiques imprégnés ou enduits sur un substrat (lingettes et masques), pour lesquels l'échantillonnage et le contexte microbiologique du produit fabriqué posent des problèmes particuliers lorsqu'il s'agit de réaliser un échantillonnage et des essais microbiologiques.
Le principe du présent document peut également être appliqué à des produits similaires (par exemple, cushion, éponges imprégnées, etc.) ou des applicateurs (par exemple, pinceau, houpette, éponge, etc.), en modifiant le mode opératoire comme approprié.
Kozmetika - Mikrobiologija - Preskušanje impregniranih izdelkov ali izdelkov, obdelanih s premazi - Robčki in maske (ISO 21322:2020)
Ta dokument vsebuje napotke za štetje in/ali odkrivanje mikroorganizmov, ki so prisotni v kozmetičnem izdelku, uporabljenem za impregnacijo ali nanos na podlago (tj. robčki in maske), pri čemer z vidika mikrobiološkega vzorčenja in preskušanja vzorčenje oziroma ugotavljanje mikrobiološkega vpliva proizvedenega izdelka predstavljata še poseben izziv. Načelo tega dokumenta se lahko uporabi tudi za preskušanje podobnih izdelkov (npr. blazina, impregnirana gobica itd.) ali aplikatorjev (npr. čopič, pudrna blazinica, gobica itd.), pri čemer se postopek po potrebi ustrezno prilagodi.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2022
Kozmetika - Mikrobiologija - Preskušanje impregniranih izdelkov ali izdelkov,
obdelanih s premazi - Robčki in maske (ISO 21322:2020)
Cosmetics - Microbiology - Testing of impregnated or coated wipes and masks (ISO
21322:2020)
Kosmetische Mittel - Mikrobiologie - Prüfung von getränkten oder beschichteten
Feuchttüchern und Masken (ISO 21322:2020)
Cosmétiques - Microbiologie - Essais sur lingettes et masques imprégnés ou enduits
(ISO 21322:2020)
Ta slovenski standard je istoveten z: EN ISO 21322:2021
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 21322
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 07.100.40
English Version
Cosmetics - Microbiology - Testing of impregnated or
coated wipes and masks (ISO 21322:2020)
Cosmétiques - Microbiologie - Essais sur lingettes et Kosmetische Mittel - Mikrobiologie - Prüfung von
masques imprégnés ou enduits (ISO 21322:2020) getränkten oder beschichteten Reinigungstüchern und
Masken (ISO 21322:2020)
This European Standard was approved by CEN on 5 December 2021.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21322:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 21322:2020 has been prepared by Technical Committee ISO/TC 217 "Cosmetics” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 21322:2021 by
Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR.
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 June 2022, and conflicting national standards shall be
withdrawn at the latest by June 2022.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 21322:2020 has been approved by CEN as EN ISO 21322:2021 without any modification.
INTERNATIONAL ISO
STANDARD 21322
First edition
2020-06
Cosmetics — Microbiology — Testing
of impregnated or coated wipes and
masks
Cosmétiques — Microbiologie — Essais sur lingettes et masques
imprégnés ou enduits
Reference number
ISO 21322:2020(E)
©
ISO 2020
ISO 21322:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 21322:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
4.1 General information . 2
4.2 Selection of the test sample . 2
4.3 Selection of the method . 3
4.4 Recovery of microorganisms from the test sample . 3
4.5 Enumeration of aerobic mesophilic microorganisms . 3
4.5.1 General. 3
4.5.2 Plate count method overview . 3
4.5.3 Membrane filtration method overview . 3
4.6 Detection of specified microorganisms by enrichment method . 4
5 Diluents, neutralizers and culture media . 4
5.1 General . 4
5.2 Diluents and neutralizers . 4
5.3 Culture media . 4
5.3.1 Media for enumeration and detection . 4
5.3.2 Media for preparation of spores of Bacillus subtilis . 4
6 Apparatus and glassware . 4
7 Strains of microorganisms . 4
8 Handling of cosmetic products and laboratory samples . 5
9 Procedure. 5
9.1 General recommendation . 5
9.2 Selection and preparation of the test sample . 5
9.2.1 Selection of the test sample . 5
9.2.2 Preparation of the initial suspension . 5
9.3 Recovery of microorganisms . 6
9.3.1 General. 6
9.3.2 Stomaching . 6
9.3.3 Shaking/Stirring . . 6
9.4 Enumeration of aerobic mesophilic microorganisms . 6
9.4.1 General. 6
9.4.2 Pour plate method . 6
9.4.3 Surface spread method . 7
9.4.4 Membrane filtration method . 7
9.4.5 Incubation . 7
9.4.6 Counting of colonies. 7
9.5 Detection of specified microorganisms by enrichment method . 8
9.5.1 General. 8
9.5.2 Test for specified microorganisms . 8
10 Expression of results . 9
10.1 Enumeration of aerobic mesophilic microorganisms . 9
10.2 Detection of specified microorganisms . 9
11 Suitability test . 9
12 Test report .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.