Bulgarian Institute for Standardization
Standards – always a step ahead
Phone: +359 2 8174 523, +359 2 8174 504
E-mail: info@bds-bg.org
1797 Sofia, 13 "Lachezar Stanchev" Str., "Izgrev" Complex
ID number: 175079183, VAT number: BG175079183
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Projects and standards

To find easily the necessary information, use the different options for advanced search below, e.g. search by technical committee; by keyword in Bulgarian/English; by reference and others.

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

60.60 Standard published

TC 62/SC 62A more

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

TC 62/SC 62A more

Medical device software - Part 2: Validation of software for medical device quality systems

60.60 Standard published

TC 62/SC 62A more

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

60.60 Standard published

ISO/TMBG more

Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

60.60 Standard published

ISO/TC 84 more

Medical devices — Post-market surveillance for manufacturers

60.60 Standard published

ISO/TC 210 more

Medical devices — Guidance on the application of ISO 14971

60.60 Standard published

ISO/TC 210 more

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

60.60 Standard published

ISO/TC 215 more

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

ISO/TC 215 more

Medical device software — Part 2: Validation of software for medical device quality systems

60.60 Standard published

ISO/TC 210 more