National Standards and Quality Department

Public Comment

No Draft Myanmar Standards Abstract/Scope Committee Open Date Close Date
101 DMMS ISO 14971:2007 Medical devices — Application of risk management to medical devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
102 DMMS ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
103 DMMS ISO 11135:2014 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
104 DMMS ISO 11137-1:2006/AMD 2:2018 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
105 DMMS ISO 15190:2003 Medical laboratories — Requirements for safety TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
106 DMMS ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
107 DMMS ISO 14155:2011/ COR 1:2011 Clinical Investigation of Medical Devices for Human Subjects TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
108 DMMS ISO 10993-1:2018 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
109 DMMS ISO 10993-2:2006 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
110 DMMS ISO 10993-3:2014 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
111 DMMS ISO 10993-4:2017 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
112 DMMS ISO 10993-5:2009 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
113 DMMS ISO 10993-6:2016 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
114 DMMS ISO 10993-7:2008 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
115 DMMS ISO 10993-9:2019 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
116 DMMS ISO 10993-10:2010 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
117 DMMS ISO 10993-11:2017 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
118 DMMS ISO 10993-12:2012 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
119 DMMS ISO 10993-13:2010 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
120 DMMS ISO 10993-14:2001 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
121 DMMS ISO 10993-15:2019 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
122 DMMS ISO 10993-16:2017 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
123 DMMS ISO 10993-17:2002 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
124 DMMS ISO 10993-18:2005 Biological Evaluation of Medical Devices TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020
125 DMMS ISO 14729:2001/AMD 1:2010 Contact Lens TC6-Technical Committee for Pharmaceutical 21.1.2020 21.3.2020

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