National foreword

This Published Document is the UK implementation of CEN ISO/TS 11137‑4:2023. It is identical to ISO/TS 11137‑4:2020. It supersedes PD ISO/TS 11137‑4:2020, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

This publication is not to be regarded as a British Standard.

Compliance with a Published Document cannot confer immunity from legal obligations.

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 July 2020.

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 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

A list of all parts in the ISO 11137 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

ISO 11137‑1 describes the requirements for the development, validation and routine control of a radiation sterilization process, and ISO 11137‑3 gives guidance on dosimetric requirements in all stages of this development, validation and control. The purpose of ISO/TS 11137‑4 is to provide additional guidance on the establishment and control of the irradiation process, including setting process target doses and verifying that the process is in a state of control.

This document addresses the establishment of methods to set process target doses and verify the process is in a state of control. Dosimetry is used during the validation of a radiation sterilization process to measure doses, and the interpretation of dosimetry results from operational and performance qualification studies is critical in establishing a process that will meet the requirements specified for minimum and maximum dose as outlined in ISO 11137‑1, ISO 11137‑2 and ISO/TS 13004.

Routine dosimetry is used to monitor that the process is in a state of control and dose specifications have been met. One purpose of this technical specification is to provide guidance on the application of a dose measurement as a tool used for monitoring an irradiation process using statistical techniques.

The guidance given is not normative and is not provided as a checklist for auditors. The guidance provides explanations and methods that are regarded as being suitable means for achieving conformity with the minimum and maximum dose specifications. Methods other than those given in the guidance may be used, if they are effective in achieving conformity with the requirements of ISO 11137‑1, ISO 11137‑2 and ISO/TS 13004.

This Technical Specification (CEN/TS) was approved by CEN on 28 May 2023 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, 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, Türkiye and United Kingdom.

European foreword

The text of ISO/TS 11137‑4:2020 has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TS 11137‑4:2023 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI.

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, Türkiye and the United Kingdom.

Endorsement notice

The text of ISO/TS 11137‑4:2020 has been approved by CEN as CEN ISO/TS 11137‑4:2023 without any modification.

1 Scope

This document provides additional guidance to that given in ISO 11137‑3 on meeting the requirements specified in ISO 11137‑1, ISO 11137‑2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.

2 Normative references

3 Terms, definitions and symbols

3.1 General

3.2 Symbols

4 Principles applied in validating and controlling an irradiation process

4.1 General

4.2 Use of the dose measurement at the monitoring location

4.3 Monitoring of critical process parameters

5 Establishing process target doses

5.1 Inputs and steps in establishing a process target dose

5.2 Performance qualification outputs

5.3 Components of σ_process

5.4 Establishing process target doses

6 Routine monitoring and control

6.1 General

6.2 Product handling

6.3 Processing of product

6.4 Special processing conditions

6.5 Process output interpretation

6.6 Collection and analysis of data

7 Release of product from the irradiation process

8 Maintaining process effectiveness

8.1 General

8.2 Assessment of changes made to the product

8.3 Assessment of changes made to the equipment

Bibliography

PD CEN ISO/TS 11137-4:2023

Sterilization of health care products. Radiation - Guidance on process control

Current

Published:

30 Jun 2023