National foreword

This British Standard is the UK implementation of EN ISO 15883‑5:2021. It is identical to ISO 15883‑5:2021.

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.

Maximum residual protein on reusable medical devices after processing

UK Department of Health’s Health Technical Memorandum 01-01 gives guidance that specifies after cleaning and disinfection, reusable surgical instruments and other medical devices should have an upper limit of acceptable protein contamination of 5 micrograms BSA equivalent per instrument side (5µg/side)1.

This British Standard, BS EN ISO 15883-5, specifies that after cleaning and disinfection, reusable surgical instruments and other medical devices should have a protein level lower than 6.4 micrograms per square centimetre (6.4 µg/cm²). ISO have defined protein per unit area in order to fix the requirement independent of instrument size.

As the size of reusable surgical instruments varies, there is a discrepancy between the UK HTM 01-01 requirements and the BS EN ISO 15883-5 requirements.

In consequence, UK sterile service managers could have conflicting requirements between UK guidance (HTM 01-01) and BS EN ISO 15883-5 for residual protein levels, depending upon the size of the reusable surgical instrument.

Surgical instruments used for high-risk procedures such as neurosurgery are typically smaller in size. Smaller surgical instruments could significantly exceed the ISO requirements, yet still meet UK guidance requirements. Conversely, larger surgical instruments could significantly exceed the UK guidance requirements for residual protein, yet still meet the ISO requirements.

EN ISO 15883-5 is listed in the European Commission’s Standardisation Request for harmonisation to Regulation (EU) 2017/745 (MDR); EN ISO 15883-5 is not listed in the UK designated standards notice 0034/21 of 1st January 2021, however other parts of the EN ISO 15883 series are listed, and ISO 15883-5 is an essential part for demonstrating conformity to the other parts.

Therefore, taking into account HTM 01-01’s requirements and BS EN ISO 15883-5 requirements, the UK committee recommends that UK sterile service managers adopt the following requirements:

For any reusable surgical instrument, the levels of residual protein should be as low as possible. After processing, there should be:
1. no more than 5 μg of protein on the side of any instrument tested, and
2. no more than 6.4 µg/cm² on any part of the instrument tested.

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 August 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 [or Project Committee] ISO/TC 198, Sterilization of health care products.

This first edition cancels and replaces ISO/TS 15883‑5:2005.

A list of all parts in the ISO 15883‑ 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

Testing of cleaning efficacy is a key aspect of establishing satisfactory performance of a washer-disinfector (WD). This testing includes type testing under simulated use conditions and can be confirmed by performance qualification testing under clinical conditions.

Cleaning efficacy of washer-disinfectors has traditionally been demonstrated by referring to different test soils and methods that had been used in several different countries. This part of ISO 15883 recommends the methods, including examples of test soils, to standardize these requirements. The individual requirements for the various types of washer-disinfectors and device reprocessing applications can vary, but this document provides the basis for the demonstration of cleaning efficacy.

Cleaning efficacy testing is performed in the WD and with associated accessories in two phases:

type testing, under simulated use conditions, with defined test soils, soiling methods and test surfaces/devices representative of design and intended applications;
performance qualification testing under clinical conditions with load(s) soiled by the most challenging load to be processed in normal practice.

NOTE This standard currently excludes the verification of cleaning of devices that might have been exposed to prions, the causative agent in transmissible spongiform encephalopathies such as Creutzfeldt-Jakob disease (CJD).

This European Standard was approved by CEN on 28 February 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 15883‑5:2021) 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 February 2022, and conflicting national standards shall be withdrawn at the latest by February 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.

This document supersedes CEN ISO/TS 15883‑5:2005.

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.

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 15883‑5:2021 has been approved by CEN as EN ISO 15883‑5:2021 without any modification.

1 Scope

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of re-usable medical devices and other items used in medical, dental, pharmaceutical and veterinary practice.

2 Normative references

3 Terms and definitions

4 Performance requirements

4.1 General

4.2 Test soil considerations

4.3 Load considerations

4.4 Cleaning efficacy test criteria

5 Testing for conformity

5.1 Cleaning test method validation

5.2 Washer-disinfector requirements

5.3 Cleaning type test

5.4 Cleaning performance qualification test

5.5 Process residuals

Bibliography

BS EN ISO 15883-5:2021

Washer-disinfectors - Performance requirements and test method criteria for demonstrating cleaning efficacy

Current

Published:

28 Feb 2022