ISO 11137-1:2006/Amd 1:2013
(Amendment)Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
Stérilisation des produits de santé — Irradiation — Partie 1: Exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux — Amendement 1
General Information
- Status
- Published
- Publication Date
- 15-Jul-2013
- Technical Committee
- ISO/TC 198 - Sterilization of health care products
- Drafting Committee
- ISO/TC 198/WG 2 - Radiation sterilization
- Current Stage
- 9599 - Withdrawal of International Standard
- Start Date
- 02-Apr-2025
- Completion Date
- 13-Dec-2025
Relations
- Effective Date
- 09-May-2020
- Effective Date
- 02-Aug-2025
Overview
ISO 11137-1:2006/Amd 1:2013 is an important amendment to the international standard that specifies the requirements for the development, validation, and routine control of radiation sterilization processes for medical devices. Published by the International Organization for Standardization (ISO), this amendment refines the procedures and definitions to ensure consistent sterility assurance when using radiation methods. The standard applies to health care products sterilized by radiation such as gamma rays, X-rays, or electron beams.
This amendment updates critical sections related to bioburden control, dose validation, and process monitoring. It harmonizes references with ISO 11137-2 and clarifies the terms "processing category" and "product family". The amendment also includes enhanced instructions for handling sterilization dose audits and managing sterilization process deviations.
Key Topics
- Radiation Sterilization Validation: Detailed requirements for developing and validating sterilization cycles to ensure effective microbial inactivation of medical devices.
- Routine Control Measures: Ensuring continuous monitoring by bioburden testing and sterilization dose audits to maintain product sterility during manufacturing.
- Processing Category & Product Family: Definitions that allow grouping products with similar sterilization needs for efficient process validation and control.
- Sterilization Dose Audit Procedures: Guidelines on conducting dose audits, especially when bioburden exceeds specified limits, and subsequent corrective actions.
- Dose Transfer Between Radiation Sources: Evaluation of material compatibility and microbicidal effectiveness when transferring sterilization between gamma, X-ray, and electron-beam sources.
- Failure Control Measures: Inclusion of safety protocols such as ceasing irradiation upon cooling system failure to prevent compromised product sterilization.
- Normalization of References: Updated normative references to ISO 11137-2 to align dose setting and verification methodologies.
Applications
ISO 11137-1:2006/Amd 1:2013 is fundamental for organizations involved in:
- Medical Device Manufacturing: Manufacturers must develop validated radiation sterilization processes compliant with this amendment, ensuring safe and sterile products for patient use.
- Sterilization Service Providers: Contract sterilizers utilize the standard to maintain assured sterility in outsourced radiation sterilization services.
- Quality and Regulatory Compliance: Helps meet regulatory requirements and audits by providing internationally recognized sterilization process controls and validation frameworks.
- Product Development: Assists design and packaging specialists in selecting materials compatible with radiation sterilization and appropriate bioburden limits.
- Healthcare Product Safety: Enhances product safety and patient protection through rigorous process monitoring and control aligned with the latest international best practices.
Related Standards
- ISO 11137-2: Establishes methods for determining sterilization doses, essential for complementary use with Part 1 in dose setting and validation.
- ISO 11737-1: Provides protocols for bioburden testing critical to monitoring microbial loads per the sterilization process requirements.
- ISO 11137-3: Specifies guidance on the development, validation, and routine control of sterilization processes using radiation, expanding on procedural details.
- ISO/IEC Directives, Part 2: Governs the drafting and approval of international standards including those related to sterilization processes.
This amendment enhances the robustness of radiation sterilization standards by emphasizing systematic bioburden control, dose verification, and risk management essential for sterile, high-quality healthcare products. Implementing ISO 11137-1:2006/Amd 1:2013 aids manufacturers and sterilizers to ensure compliance, product safety, and operational excellence in medical device sterilization using radiation.
Frequently Asked Questions
ISO 11137-1:2006/Amd 1:2013 is a standard published by the International Organization for Standardization (ISO). Its full title is "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1". This standard covers: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
ISO 11137-1:2006/Amd 1:2013 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 11137-1:2006/Amd 1:2013 has the following relationships with other standards: It is inter standard links to ISO 11137-1:2006, ISO 11137-1:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 11137-1:2006/Amd 1:2013 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 11137-1
First edition
2006-04-15
AMENDMENT 1
2013-07-15
Sterilization of health care products —
Radiation — Part 1: Requirements for
development, validation and routine
control of a sterilization process for
medical devices
AMENDMENT 1
Stérilisation des produits de santé — Irradiation — Partie 1:
Exigences relatives à la mise au point, à la validation et au contrôle de
routine d’un procédé de stérilisation pour les dispositifs médicaux
AMENDEMENT 1
Reference number
ISO 11137-1:2006/Amd.1:2013(E)
©
ISO 2013
ISO 11137-1:2006/Amd.1:2013(E)
© ISO 2013
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
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
ISO 11137-1:2006/Amd.1:2013(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to ISO 11137-1:2013 was prepared by Technical Committee ISO/TC 198, Sterilization of
health care products.
ISO 11137-1:2006/Amd.1:2013(E)
Sterilization of health care products — Radiation — Part 1:
Requirements for development, validation and routine
control of a sterilization process for medical devices
AMENDMENT 1
Page 2, Normative references
Replace the reference to ISO 11137-2:2006 with the following:
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Page 6, Terms and definitions
Replace entry 3.29 with the following:
3.29
processing category
collection of different product or product families that can be sterilized together
NOTE Processing categories can be based on, for instance, composition, density or dose requirements.
Replace entry 3.31 with the following:
3.31
product family
group of product possessing characteristics that allow them to be sterilized using given defined
process conditions
NOTE Bioburden on members of a product family destined for radiation sterilization has to comprise similar
numbers and types of microorganisms.
Page 11, 6.2.5
Add the following item to the list:
m) the means of ceasing irradiation if failure of the target cooling system occurs.
Page 12, 7.4
Replace the reference “ISO 11137-2:2006, Clause 4” with “ISO 11137-2”.
Page 12, 8.2.2, NOTE to a)
Replace the reference “6.1 of ISO 11137-2:2006” with “ISO 11137-2”.
ISO 11137-1:2006/Amd.1:2013(E)
Page 12, 8.2.2, NOTE to b)
Replace the reference “6.2 of ISO 11137-2:2006” with “ISO 11137-2”.
Page 17, 12.1.1 a)
Replace a) with:
a) determinations of bioburden to monitor the number of microorganisms present on product in
relation to a specified bioburden limit, and
Page 18, 12.1.2.5
Replace the first paragraph up to and including b) 1) with the followi
...
NORME ISO
INTERNATIONALE 11137-1
Première édition
2006-04-15
AMENDEMENT 1
2013-07-15
Stérilisation des produits de santé
— Irradiation — Partie 1: Exigences
relatives à la mise au point, à la
validation et au contrôle de routine
d’un procédé de stérilisation pour les
dispositifs médicaux
AMENDEMENT 1
Sterilization of health care products — Radiation — Part 1:
Requirements for development, validation and routine control of a
sterilization process for medical devices
AMENDEMENT 1
Numéro de référence
ISO 11137-1:2006/Amd.1:2013(F)
©
ISO 2013
ISO 11137-1:2006/Amd.1:2013(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2013
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Publié en Suisse
ii © ISO 2013 – Tous droits réservés
ISO 11137-1:2006/Amd.1:2013(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (CEI) en ce qui concerne
la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives
ISO/CEI, Partie 2.
La tâche principale des comités techniques est d’élaborer les Normes internationales. Les projets de
Normes internationales adoptés par les comités techniques sont soumis aux comités membres pour vote.
Leur publication comme Normes internationales requiert l’approbation de 75 % au moins des comités
membres votants.
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable de
ne pas avoir identifié de tels droits de propriété et averti de leur existence.
L’Amendement 1 à l’ISO 11137-1:2006 a été élaboré par le comité technique ISO/TC 198, Stérilisation des
Produits de Santé.
ISO 11137-1:2006/Amd.1:2013(F)
Stérilisation des produits de santé — Irradiation —
Partie 1: Exigences relatives à la mise au point, à la
validation et au contrôle de routine d’un procédé de
stérilisation pour les dispositifs médicaux
AMENDEMENT 1
Page 2, Article 2
Remplacer la référence à l’ISO 11137-2:2006 par la suivante:
«ISO 11137-2, Stérilisation des produits de santé — Irradiation — Partie 2: Établissement de la dose
stérilisante»
Page 6, Article 3
Remplacer l’entrée 3.29 par la suivante:
3.29
catégorie de traitement
groupe de produits ou familles de produits qui peuvent être stérilisés ensemble
NOTE Les catégories de traitement peuvent, par exemple, être basées sur les exigences de composition, de
masse volumique ou de dose.
Remplacer l’entrée 3.31 par la suivante:
3.31
famille de produits
groupe de produits possédant des caractéristiques permettant leur stérilisation selon un procédé spécifié
NOTE La charge biologique présente sur les membres d’une famille de produits destinés à être stérilisés par
irradiation doit être constituée de micro-organismes de même type et présents dans les mêmes proportions.
Page 11, 6.2.5
Ajouter l’élément suivant à la liste:
m) les moyens permettant d’arrêter l’irradiation en cas de défaillance du système de
refroidissement de la cible.
Page 12, 7.4
Remplacer la référence «ISO 11137-2:2006, Article 4» par «ISO 11137-2».
Page 12, 8.2.2, NOTE de a)
Remplacer la référence «ISO 11137-2:2006, 6.1» par «ISO 11137-2».
Page 12, 8.2.2, NOTE de b)
Remplacer la référence «ISO 11137-2:2006, 6.1» par «ISO 11137-2».
Page 17, 12.1.1 a)
ISO 11137-1:2006/Amd.1:2013(F)
Remplacer le texte de a) par le suivant:
a) déterminations de la charge biologique pour surveiller le nombre de micro-organismes présents sur
le produit par rapport à une charge biologique limite spécifiée, et
Page 18, 12
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...