SS ISO 11139-2018 - Sterilisation of health care products—Vocabulary of terms used in sterilisation and related equipment and process standards - Preview

Sep 28, 2026

Uploaded by Ben

Singapore Standard SS 11139:2018 defines terminology used in the sterilisation of health care products. It aligns identically with ISO 11139:2018 and sets a structured vocabulary covering terms related to sterilisation equipment and processes. The publication includes a national foreword, scope, normative references, and a terms-and-definitions framework, with an informative annex summarising where each term is covered in Clause 3. Approved on 9 November 2018.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Contents Page

National Foreword

Foreword

Introduction

1. Scope

2. Normative references

3. Terms and definitions

Annex A (informative) Summary of standards

Bibliography

SINGAPORE STANDARD Sterilisation of health care products—Vocabulary of terms used in sterilisation and related equipment and process standards SS 11139 : 2018 ISO 11139 : 2018 , IDT (ICS 11.080.01; 01.040.11) SINGAPORE STANDARD Sterilisation of health care products—Vocabulary of terms used in sterilisation and related equipment and process standards All rights reserved. Unless otherwise specified , no part of this Singapore Standard maybe reproduced or utilised in any form or by any means, electronic or mechanical, including photocopying and microfilming, without permission in writing from Enterprise Singapore. Request for permission can be sent to: [standards@enterprisesg.gov.sg](standards@enterprisesg.gov.sg). © ISO 2018 – All rights reserved © Enterprise Singapore 2018 ISBN 978-981-48-3548-0 This Singapore Standard was approved on 9 November 2018 by the Biomedical and Health Standards Committee under the purview of the Singapore Standards Council. First published, 2019 The Biomedical and Health Standards Committee, appointed by the Standards Council, consists of the following members: Chairman Deputy Chairmen Advisor Secretary Members Name : Dr Yong Chern Chet: Mr Vincent Cheung Ms Selina Seah Ms Wong Woei Jiuang: Ms Jacqueline Monteiro : Ms Iris Peng : Mr Alec Chow Boon Kuan Mr Chung Kwong Yuew Ms Heidi Goh Prof James Goh Dr Lai Choon Sheen Dr Christopher Lam Assoc Prof Leo Hwa Liang Dr Lin Jianhua Dr Leonard Loh Assoc Prof Eddie Ng Yin Kwee Dr Ong Siew Hwa Dr Padmanabhan Saravanan Mr Peh Ruey Feng Ms Celine Tan Prof Tan Puay Hoon Ms Wang Dan Dr Sidney Yee Dr Zhou Zhihong Capacity Individual Capacity Individual Capacity Changi General Hospital Health Sciences Authority Individual Capacity Singapore Manufacturing Federation – Standards Development Organisation Medtronic International Ltd Temasek Polytechnic (BioMedical Engineering Faculty) Singapore Manufacturing Federation (Medical Technology Industry Group) Biomedical Engineering Society (Singapore) Eu Yan Sang International Ltd Health Sciences Authority National University of Singapore TüVSüD PSB Pte Ltd Nanyang Polytechnic Nanyang Technological University Acumen Research Laboratories Pte Ltd Temasek Polytechnic (Centre of Innovation for Complementary Health Products) Advent Access Pte Ltd Enterprise Singapore Singapore Health Services Pte Ltd Biosensors International Group Diagnostics Development (DxD) Hub Singapore Bioimaging Consortium The Technical Committee on Quality Management Systems, appointed by the Biomedical and Health Standards Committee, consists of representatives from the following organisations: Name Capacity Chairman : Ms Heidi Goh Individual Capacity Secretary : Ms Iris Peng Singapore Manufacturing Federation – Standards Development Organisation Members : Ms Jasmine Chan Veredus Laboratories Pte Ltd Mr Chin Kai Hwee Biosensors International Group Ms Katherine Goh Singapore Accreditation Council Dr Christopher Lam Health Sciences Authority Mr Nishith Desai Medtronic International Ltd Ms Grace Tan Edward Lifesciences (Singapore) Pte Ltd The National Mirror Working Group on ISO/TC 210, appointed by the Technical Committee to assist in the preparation of this standard, comprises the following experts who contribute in their individual capacity: Name Convenor : Dr Margam Chandrasekaran Secretary : Mr Kevin Tan Members : Ms Heidi Goh Ms How Pei Sin Ms Audrey Lee Mr Liew Ee Bin Mr Narayanan Sethu Mr Caleb Ng Mr Paul Tan The organisations in which the experts of the National Mirror Working Group are involved are: Access-2-Healthcare BioPharmaSpec UK Ltd Sanmina Corporation Singapore Singapore Manufacturing Federation (Medical Technology Industry Group) SysteMED Pte Ltd TüVSüD PSB Pte Ltd Wise Consultants and Services Pte Ltd (blank page) Contents Page National Foreword ..............................................

FAQs

What does SS ISO 11139:2018 cover?

It covers the vocabulary of terms used in sterilisation of health care products, including related equipment and process standards.

How is SS ISO 11139:2018 related to ISO 11139:2018?

The standard is identical with ISO 11139:2018, “Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards”.

What are the main sections inside the document?

The document includes scope, normative references, and terms and definitions, plus an informative annex summarising standards where each term is included.

Sep 28, 2026

Uploaded by Ben