Below is a listing of projects past and present carried out by the Saint Lucia Bureau of Standards.
Medical devices — Quality management systems — Requirements for regulatory purposes
90.93 Standard confirmed
Medical devices — Application of risk management to medical devices
60.60 Standard published
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
60.60 Standard published
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1
20.00 New project registered in TC/SC work programme
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
90.92 Standard to be revised
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
90.93 Standard confirmed
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
90.99 Withdrawal of Standard proposed by TC or SC
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
90.99 Withdrawal of Standard proposed by TC or SC
Guidance for assessment and evaluation of changes to drug delivery systems
60.60 Standard published
Medical devices — Information to be supplied by the manufacturer
60.60 Standard published
Maintenance management program for medical equipment
30.60 Close of voting/ comment period
Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
60.60 Standard published
Medical devices — Post-market surveillance for manufacturers
60.60 Standard published
Medical devices — Guidance on the application of ISO 14971
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
60.60 Standard published
Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
60.60 Standard published
Medical device software — Part 2: Validation of software for medical device quality systems
60.60 Standard published