SINGAPORESTANDARD
Biologicalevaluationofmedical devices
-Part 1:Evaluationand testingwithin a riskmanagementprocess
Biologicalevaluationofmedicaldevices
Part 1 : Evaluation and testing within a risk management process
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 includingoes d oy u u sd nm u pe doRequest for permission can be sent to: standards(@enterprisesg-gov.sg.
ISO 2018 All rights reserved @ Enterprise Singapore 2018
ISBN 978-981-48-3525-1
SSISO10993-1:2018
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:
Name CapacityChairman :Dr Yong Chern Chet Individual Capacity1stDeputy Chairman :Ms Wong Woei Jiuang Health Sciences Authority2Deputy Chairman ：Mr Vincent Cheung Individual Capacity3d Deputy Changi General HospitalAdvisor Chairman :Ms Selina Seah Individual CapacitySecretary :Mr Kevin Tan :Ms Jacqueline Monteiro Singapore Manufacturing Federation -Standards Development OrganisationMembers :Mr Alec Chow Boon Kuan Medtronic International LtdMr Chung Kwong Yuew Temasek Polytechnic (BioMedical Engineering Faculty)Ms Heidi Goh Singapore Manufacturing Federation (MedicalTechnology Industry Group)Dr Lai Choon Sheen Prof James Goh Biomedical Engineering Society (Singapore) Eu Yan Sang International LtdDr Christopher Lam Health Sciences Authority (Medical DevicesBranch)Assoc Prof Leo Hwa Liang National University of SingaporeDr Lin Jianhua Dr Leonard Loh Nanyang Polytechnic (BioMedical Engineering TUV SUD PSB Pte LtdHub)Assoc Prof Eddie Ng Yin Kwee Nanyang Technological UniversityDr Ong Siew Hwa Acumen Research Laboratories Pte LtdDr Padmanabhan Temasek Polytechnic (Centre of Innovation forMr Peh Ruey Feng Saravanan Advent Access Pte Ltd Complementary Heaith Products)Ms Celine Tan Enterprise SingaporeProf Tan Puay Hoon Singapore Heaith Services Pte LtdMs Wang Dan Biosensors International GroupDr Zhou Zhihong Dr Sidney Yee DxD Hub Singapore Bioimaging Consortium
SSISO10993-1:2018
The Technical Committee on Medical Devices appointed by the Biomedical and Health Standardsthe following organisations: Committee and responsible for the preparation of this standard consists of representatives from
Name CapacityChairman :Prof James Goh Individual CapacitySecretary :Mr Kevin Tan Singapore Manufacturing Federation- StandardsDevelopment OrganisationMembers :Mr Chua Chui Khim Becton Dickinson Medical (S) Pte LtdDr Christopher Lam Health Sciences AuthorityAssoc Prof Leo Hwa Liang Biomedical Engineering Society (Singapore)Susf w 0 Ms Iris Tan OsteoporeInternationalPte Ltd Advent Access Pte Ltd
The National Mirror Working Group on ISO/TC 194 appointed by the Technical Committee to assist in the preparation of this standard prises the following experts who contribute in theirindividual capacity:
NameDeputy Convenor :Dr Margam ChandrasekaranConvenor :Dr Ong Lee LeeSecretary :Mr Kevin TanMembers A/Prof Chew Sing Yan Mr Fan MingweiMs Heidi GohProf James GohMr Peter HaywoodDr Lim jing Prof James Hui Hoi PoA/Prof Phan Toan-ThangProf Seeram RamakrishnaMr Tan Ming JieDr Tang Kin Fai
SSISO10993-1:2018
The organisations in which the experts of the Working Group are involved are:
Biomedical Engineering Society (Singapore)Cordlife Group LimitedDenova Sciences Pte Ltd Edwards Lifesciences (Singapore) Pte LtdEmcero Pte LtdHealth Sciences AuthorityNanyang Technological UniversityNational University of SingaporeOsteopore International Pte Ltd Wise Consultants and Services Pte Ltd
