National foreword

This British Standard is the UK implementation of EN ISO 11138‑8:2021. It is identical to ISO 11138‑8:2021.

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 31 July 2021.

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 11138 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

A biological indicator incubation time is the minimum period of cultivation required before making a final determination that a biological indicator is negative (shows no growth). The reference incubation time for biological indicators for established sterilization processes such as moist heat and ethylene oxide is 7 d (see ISO 11138‑1:2017). In some instances where biological indicator results are needed as part of the product release process, a 7-day incubation time might not be practical. This is especially the case where biological indicators are used to monitor sterilization processes in hospitals or other health care facilities such as dental or general practitioner offices.

The purpose of a reduced incubation time procedure is to demonstrate recovery of the surviving test organisms within the specified reduced incubation time period. The reduced incubation time is a function of the test method and conditions used to establish the incubation time and is independent of the process parameters for the sterilization method used to deliver the lethality.

Biological indicators with an incubation time of less than 7 d (a Reduced Incubation Time, or RIT) have been in use since the 1970s. The methodology to determine the RIT was originally created by the biological indicator manufacturers. Later, the United States Food and Drug Administration published guidance for manufacturers seeking regulatory clearance to market biological indicators to health care facilities in the United States (see Reference [1]). This guidance contained a protocol for validating an incubation time that was less than 7 d. This document was specific to regulations for commercial practices in a single country and did not address requirements for RIT methodology outside of that application. The purpose of this document is to describe an internationally agreed approach to the validation of the reduced incubation time of a biological indicator.

This European Standard was approved by CEN on 24 June 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 foreword

This document (EN ISO 11138‑8:2021) 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 January 2022, and conflicting national standards shall be withdrawn at the latest by January 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/national committee. A complete listing of these bodies can be found on the CEN websites.

EN ISO 11138 consists of the following parts, under the general title Sterilization of health care products — Biological indicators:

Part 1: General requirements

Part 2: Biological indicators for ethylene oxide sterilization processes

Part 3: Biological indicators for moist heat sterilization processes

Part 4: Biological indicators for dry heat sterilization processes

Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Part 6: Biological indicators for hydrogen peroxide sterilization processes

Part 7: Guidance for the selection, use and interpretation of results

Part 8: Method for validation of a reduced incubation time for a biological indicator

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 11138‑8:2021 has been approved by CEN as EN ISO 11138‑8:2021 without any modification.

1 Scope

1.1

This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138‑1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.

NOTE For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load.

1.2

This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT.

1.3

This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.

NOTE The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.

2 Normative references

3 Terms and definitions

4 General

4.1

4.2

4.3

4.4

4.5

5 Selection and preparation of samples

5.1

5.2

6 Exposure and culturing

6.1

6.2

6.3

6.4

6.5

7 Determination of reduced incubation time

7.1

7.2

7.3

Bibliography

BS EN ISO 11138-8:2021

Sterilization of health care products. Biological indicators - Method for validation of a reduced incubation time for a biological indicator

Current

Published:

31 Jul 2021