CEN ISO/TS 16775:2014
(Main)Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
ISO/TS 16775:2014 provides guidance for the application of the requirements contained in ISO 11607‑1 and ISO 11607‑2. It does not add to, or otherwise change, the requirements of ISO 11607‑1 and/or ISO 11607‑2. It is an informative document, not normative, and does not include requirements to be used as basis of regulatory inspection or certification assessment activities.
The guidance can be used to better understand the requirements of ISO 11607‑1 and/or ISO 11607‑2 and illustrates some of the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required to be used to demonstrate compliance with them.
Guidelines are given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given.
ISO/TS 16775:2014 provides information for health care facilities and for the medical devices industry. It does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a "sterile field" or transport of contaminated items, other regulatory standards will apply.
Verpackungen für in der Endanwendung sterilisierte Medizinprodukte - Leitfaden für die Anwendung von ISO 11607-1 und ISO 11607-2 (ISO/TS 16775:2014)
Diese Technische Spezifikation enthält Leitlinien für die Anwendung der in ISO 11607-1 und ISO 11607-2 enthaltenen Anforderungen. Durch das vorliegende Dokument werden die Anforderungen von ISO 11607-1 und/oder ISO 11607-2 weder ergänzt noch verändert. Dies ist ein informatives, kein normatives Dokument. Das vorliegende Dokument enthält keine Anforderungen, die als Grundlage für regulatorische Überwachungen oder für Abläufe der Zertifizierungsbewertung zu verwenden sind.
Dieser Leitfaden kann verwendet werden, um die Anforderungen von ISO 11607-1 und/oder ISO 11607-2 besser zu verstehen und um einige der zahlreichen Verfahren und Ansätze, die zur Erfüllung der Anforderun-gen von ISO 11607-1 und/oder ISO 11607-2 zur Verfügung stehen, zu veranschaulichen. Es ist nicht erforderlich, das vorliegende Dokument zum Nachweis der Einhaltung Internationaler Normen anzuwenden.
Dieses Dokument enthält Leitlinien zur Bewertung, Auswahl und Verwendung von Verpackungsmaterialien, vorgefertigten Sterilbarrieresystemen, Sterilbarrieresystemen und Verpackungssystemen. Es enthält außer-dem Hinweise zu den Validierungsanforderungen an Prozesse der Formgebung, Siegelung und der Zusammenstellung.
Dieses Dokument enthält Informationen für Einrichtungen des Gesundheitswesens (siehe Abschnitt 3) und für die Medizinprodukteindustrie (siehe Abschnitt 4).
Dieses Dokument enthält keine Leitlinien für die Verwendung von Verpackungsmaterialien und Verpackungs-systemen nach dem Öffnen. Für die Verwendung von Verpackungen für andere Zwecke, wie z. B. als „steriles Feld“ oder den Transport kontaminierter Artikel, sind andere regulatorische Standards anwendbar.
Emballages des dispositifs médicaux stérilisés au stade terminal - Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2 (ISO/TS 16775:2014)
Embalaža za končno sterilizirane medicinske pripomočke - Smernice za uporabo ISO 11607-1 in ISO 11607-2 (ISO/TS 16775:2014)
Standard CEN ISO/TS 16775 podaja smernice za uporabo zahtev standardov ISO 11607-1 in ISO 11607-2. Ne dopolnjuje ali kako drugače spreminja zahtev standarda ISO 11607-1 in/ali ISO 11607-2. To je informativni in ne normativni dokument. Ne vključuje zahtev, ki naj se uporabljajo na osnovi predpisanega pregleda ali aktivnosti ugotavljanja certificiranja. Smernice je mogoče uporabiti za boljše razumevanje zahtev standarda ISO 11607-1 in/ali ISO 11607-2 ter prikazujejo nekatere metode in pristope, ki so na voljo za izpolnjevanje zahtev mednarodnih standardov. Ni zahtevano, da se ta dokument uporablja za dokaz skladnosti z njimi. Smernice so podane za vrednotenje, izbiro in uporabo materialov za embalažo, izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov in sistemov embalaže. Podane so tudi smernice o zahtevah za validacijo procesov oblikovanja, označevanja in sestavljanja. Ta tehnična specifikacija podaja informacije za zdravstvene ustanove (glejte točko 3) in panogo medicinskih pripomočkov (glejte točko 4). Ne podaja smernic za uporabo materialov za embalažo in sistemov po njihovem odprtju. Za uporabo embalaže v druge namene, kot sta »sterilno polje« ali transport kontaminiranih predmetov, veljajo drugi regulativni standardi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2014
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNH6PHUQLFH]DXSRUDER
,62LQ,62 ,6276
Packaging for terminally sterilized medical devices - Guidance on the application of ISO
11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
Verpackungen für in der Endverpackung sterilisierte Medizinprodukte - Tei 3: Leitfaden
für die Anwendung von ISO 11607-1 und ISO 11607-2 (ISO/TS 16775:2014)
Emballages des dispositifs médicaux stérilisés au stade terminal - Lignes directrices
relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2 (ISO/TS 16775:2014)
Ta slovenski standard je istoveten z: CEN ISO/TS 16775:2014
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL SPECIFICATION
CEN ISO/TS 16775
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
May 2014
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Guidance
on the application of ISO 11607-1 and ISO 11607-2 (ISO
16775:2014)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endanwendung sterilisierte
terminal - Lignes directrices relatives à l'application de l'ISO Medizinprodukte - Leitfaden für die Anwendung von ISO
11607-1 et l'ISO 11607-2 (ISO 16775:2014) 11607-1 und ISO 11607-2 (ISO 16775:2014)
This Technical Specification (CEN/TS) was approved by CEN on 18 February 2014 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 16775:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (CEN ISO/TS 16775:2014) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102 “Sterilizers for
medical purposes” the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 16775:2014 has been approved by CEN as CEN ISO/TS 16775:2014 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 16775
First edition
2014-05-15
Packaging for terminally sterilized
medical devices — Guidance on the
application of ISO 11607-1 and ISO
11607-2
Emballages des dispositifs médicaux stérilisés au stade terminal —
Lignes directrices relatives à l’application de l’ISO 11607-1 et l’ISO
11607-2
Reference number
ISO/TS 16775:2014(E)
©
ISO 2014
ISO/TS 16775:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, 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
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Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO/TS 16775:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Terms and definitions . 1
3 Guidance for health care facilities . 2
3.1 Test methods . 2
3.2 Guidance for conformance to ISO 11607-1 . 2
3.3 Guidance on conformance to ISO 11607-2, Validation requirements for forming,
sealing and assembly processes .10
3.4 Quality system .19
4 Guidance for industry .20
4.1 General guidance .20
4.2 Design inputs .20
4.3 Selection and evaluation of materials .21
4.4 Sterile barrier system and protective packaging design (packaging
system development) .22
4.5 Packaging process feasibility evaluation .24
4.6 Sterile barrier system design feasibility evaluation .25
4.7 Validation of sterile barrier system manufacturing process .26
4.8 Packaging system design validation .28
4.9 Revalidation .29
Annex A (informative) Selection, evaluation and testing of packaging materials and sterile barrier
systems — Guidance for industry and health care facilities .31
Annex B (informative) Sterilization considerations — Guidance for industry and health
care facilities.39
Annex C (informative) Examples of wrapping methods — Guidance for health care facilities .47
Annex D (informative) Validation plan documents — Guidance for health care facilities .54
Annex E (informative) Installation qualification documentation — Guidance for health
care facilities.68
Annex F (informative) Operational qualification documentation — Guidance for health
care facilities.73
Annex G (informative) Performance qualification documentation — Guidance for health
care facilities.77
Annex H (informative) Addressing worst-case requirements — Guidance for industry and health
care facilities.81
Annex I (informative) Generating a final packaging system validation protocol — Guidance
for industry .83
Annex J (informative) Design inputs — Medical device attributes — Guidance for industry .86
Annex K (informative) Risk analysis tools — Guidance for industry and health care facilities .91
Annex L (informative) Considerations for sampling plans — Guidance for health care facilities .93
Annex M (informative) Stability testing (ISO 11607-1:2006, 6.4) — Guidance for industry .95
Annex N (informative) Use of the Internet — Guidance for industry and health care facilities .96
Annex O (informative) Test method validation — Guidance for industry .97
Annex P (informative) Use of contract packagers — Guidance for industry and health
care facilities.98
ISO/TS 16775:2014(E)
Annex Q (informative) Guidance on establishing process parameters — Guidance for industry .99
Annex R (informative) Investigation failure — Guidance for industry and health care facilities .105
Annex S (informative) Packaging manufacturing process and packaging system design feasibility
evaluation — Guidance for industry .108
Bibliography .111
iv © ISO 2014 – All rights reserved
ISO/TS 16775:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
...
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