National foreword

This British Standard is the UK implementation of EN ISO 11607‑3:2026. It is identical to ISO 11607‑3:2026.

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.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2026.

This European Standard was approved by CEN on 29 August 2026.

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, Czechia, 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

This document (EN ISO 11607‑3:2026) has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of 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 March 2027, and conflicting national standards shall be withdrawn at the latest by March 2027.

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/national committee. 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 11607‑3:2026 has been approved by CEN as EN ISO 11607‑3:2026 without any modification.

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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

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, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 102, Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

A list of all parts in the ISO 11607 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 11607‑1 and ISO 11607‑2 specify requirements for the design and validation of sterile barrier systems for terminally sterilized medical devices, and the validation requirements for manufacturing processes of sterile barrier systems, respectively. The heat sealing of a sterile barrier system is critical to the maintenance of sterile barrier integrity to the point of use; however, there is little content available for process development in the current edition of ISO 11607‑2.

This document specifies requirements for the development of heat sealing processes to meet sterile barrier seal design requirements. A thorough development process with a high-quality output is an important input to an efficient validation of the process. While a successful validation is essential to ensure the safety of terminally sterilized medical devices, there is no intention to imply that the process development approach proposed in this document is the only valid approach. Users of this document can use the activities described in this document to control risks associated with heat sealing processes, if they find it appropriate. Additionally, this document specifies a process for documenting the equivalence of heat sealing processes which can be a benefit to users in support of change control activities since it can create the basis to leverage the efforts over a range of heat sealing equipment or over a sterile barrier system family.

This document is intended for use by industrial manufacturers engaged in the design and development of sterile barrier systems and heat sealing processes. Effective application of the requirements described in this document requires proficiency in design of experiment (DOE) methodologies and access to the requisite testing resources for result evaluation. Producers of preformed sterile barrier systems, as well as medical device manufacturers, rely heavily on heat sealing, among other techniques, to create sterile barrier systems that ensure device integrity and sterility at various stages of distribution and handling of sterile devices until the point of use and aseptic presentation. This process often involves the operation of multiple, interchangeable heat sealers to produce commercial quantities of sterile barrier systems.

For healthcare facilities (e.g. hospitals), ISO/TS 16775:2021, Annex B contains all relevant guidance for sterile barrier system closure technologies including sealing, reusable container closures and wrapping processes.

1 Scope

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.

This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.

This document applies to both preformed sterile barrier systems and sterile barrier systems.

This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.

This document is intended to be used prior to process validation.

NOTE ISO 11607‑2 provides requirements for process specification and process validation.

2 Normative references

3 Terms and definitions

4 General requirements

4.1 Quality systems

4.2 Risk management

4.3 Sampling

4.4 Test methods

4.5 Documentation

5 Process development

5.1 General

5.2 Process development activities

5.3 Predetermined SBS specification(s)

5.4 Draft process specification

5.5 Initial process risk analysis

5.6 Process variables

5.7 Initial process control and monitoring plans

5.8 Process specification

5.9 Process risk management plan

6 Process equivalence

6.1

6.2

6.3

Bibliography