Development of the Primary Standard for IAEA TRS-457 at OAP, Thailand

Rindhatayathon, Pongphanot; Koonkana, K.; Rungseesumran, T.; Pungkun, Vithit

doi:10.1007/s12647-022-00584-z

MAPAN

2022

DOI: 10.1007/s12647-022-00584-z

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Development of the Primary Standard for IAEA TRS-457 at OAP, Thailand

Pongphanot Rindhatayathon

K. Koonkana

T. Rungseesumran³

et al.

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2023

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“…National level efforts are being initiated at many countries to address RM requirement in this critical area that has impact on health and environment. Risk levels warrant strict regulatory controls in this research[14,15].Website: ijetms.in Issue: 5 Volume No.7 September -October -2023 DOI:10.46647/ijetms.2023.v07i05.025 ISSN: 2581-4621 Evaluations in medical device development Materials used in medical devices development are to be qualified for safe use in clinical requirements. International standards in the series of ISO 10993 draw attention in this specialized application area through a set of preclinical in-vitro and in-vivo biological evaluations.…”

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confidence: 99%

Availability of Reference Materials for Improving Quality of Life within Scientific and Industrial Framework

Dr. Remya NS,

Leena Joseph

2023

IJETMS

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Established metrological traceability to SI (system international) is the strength of any reliable quality management system. Accreditation of facilities and Good laboratory practices in conducting studies drives all measurement involved in the system with traceability either through calibration or by use of Reference Material (RM). Whenever the process of calibration become not convenient, RMs could take up the role for assuring reliability in results with stated level of confidence with minimum possible uncertainty in results. Standardizing clinical diagnostics, qualifying different developmental stages of bio-medical devices and biomaterials, development and constructive use of radio nuclear techniques, control of environmental pollution, etc invites special attention in improving quality of life. Onsets of pandemic conditions like SARS – CoV 2 (severe acute respiratory syndrome -Corona Virus 2) triggers emergencies for regulatory approvals. Availability of certified property values of RMs has significant role in qualifying such tests and evaluations. They may support quick release of products like medical devices into market for routine use. Property value of RMs could be quantitative or qualitative. Even though a large quantum of work has established RMs with quantitative property value, the other type still remains as minimally addressed in many countries. Remarkable efforts done at international research laboratories supplies RMs traceable to NIST (National Institute Standards and Technology, USA), USP (United States Pharmacopeia), NPL (National Physical Laboratory) India etc. RM requirements in critical application areas like healthcare are not sufficiently visible to the scientific community and hence do not satisfy global demands. This feature presents an overview of present status on the issue.

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confidence: 99%

Availability of Reference Materials for Improving Quality of Life within Scientific and Industrial Framework

Dr. Remya NS,

Leena Joseph

2023

IJETMS

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Development of the Primary Standard for IAEA TRS-457 at OAP, Thailand

Cited by 1 publication

References 13 publications

Availability of Reference Materials for Improving Quality of Life within Scientific and Industrial Framework

Availability of Reference Materials for Improving Quality of Life within Scientific and Industrial Framework

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