European and International standards

When specifying packaging for terminally sterilised medical devices, identify the full document designation. A base standard, a separate amendment and a consolidated national publication are different purchasing and reference options. What the amendment addresses ISO 11607-1:2019/Amd 1:2023 adds risk-management application to the Part 1 requirements for materials, sterile barrier systems and packaging systems. ISO records its publication in September 2023. A national adoption can have a different publication date. The EVS record for EN ISO 11607-1:2020/A1:2023 identifies an amendment publication. It should not be described as a new standalone edition containing the entire base standard. Check what your copy contains Confirm the base standard and all applicable amendments. Check whether the supplied document is amendment-only or consolidated. Distinguish European additions, such as an A11 amendment, from the international Amd 1. Record the publication actually used in the assessment a...

The Ecodesign for Sustainable Products Regulation, or ESPR, is adopted legislation rather than an outstanding proposal. Regulation (EU) 2024/1781 entered into force in July 2024. A framework with product-specific implementation The regulation establishes a framework for ecodesign requirements. It does not mean that every possible requirement became applicable to every product on the day the framework entered into force. Product scope, delegated acts and application dates need to be checked for the product concerned. The Commission's ESPR introduction explains the framework. Its 2025–2030 working-plan overview identifies implementation priorities; a planned action is not the same as an already applicable product rule. Digital product passports need the same scope check The framework provides for digital product passports. Do not assume that an identical passport obligation or data set applies immediately to every product. Establish the relevant product rules, information requireme...

ISO 13485 specifies requirements for a quality management system in the medical-device field. Its focus is how an organisation manages relevant processes; a certificate against the standard is not a universal product approval. Start with the organisational scope ISO's publication record identifies ISO 13485:2016 as the current edition, reviewed and confirmed in 2025. Organisations involved in device design, production, installation, servicing and related supply activities can have relevant responsibilities within its scope. Define which activities, sites and services the organisation's system covers. Then connect procedures and records to the work actually performed. A supplier carrying out a limited activity should not imply that its certificate covers the entire device lifecycle. Three things to check in a certification claim The organisation and locations named on the certificate. The activities and scope covered by the assessment. The applicable standard, certificate statu...