Product families
- Electrical medical equipment
- Non-active instruments and devices
- Implantable devices
- Medical software and connected devices
These links search words in indexed titles within the product group. A search match is a candidate for scope review.
Product scope and configuration
Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls. Define the features below in the product description. They establish the questions to take to the official scope and to the technical evidence.
Keep the description tied to the supplied configuration, including accessories, settings and installation conditions. Record any differences between the product offered and the object examined.
Standard reference discovery
1,857 bibliographic discovery matches in this group. Matches use official titles, reference families and available ICS classification.
Information supplied by the manufacturer with medical devices
Information supplied by the manufacturer of medical devices
Information supplied by the manufacturer of medical devices
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance
Evidence priorities
- Intended purpose
Define the object and the question, then identify the controlled record that answers it. Keep the basis, supporting evidence and limits with the resulting conclusion.
- Classification rationale
Define the object and the question, then identify the controlled record that answers it. Keep the basis, supporting evidence and limits with the resulting conclusion.
- Risk management
Define the object and the question, then identify the controlled record that answers it. Keep the basis, supporting evidence and limits with the resulting conclusion.
- Verification and performance evidence
Retain the method, assessed configuration, conditions, results and decision together. A report title alone does not establish the scope or limits of the conclusion.
- Clinical evidence scope
Define the object and the question, then identify the controlled record that answers it. Keep the basis, supporting evidence and limits with the resulting conclusion.
A complete file connects the product definition, requirements, assessment evidence and production changes. Read the standard's full requirements when designing the assessment; the index provides the official entry point.
Award evidence schedule for this product group →
The free IESQ Award requires the applicable baseline to be satisfied and a supported margin in a relevant core characteristic. A standard-reference match alone does not establish eligibility.
Legislation research routes
- Low Voltage (LVD)
- Pressure equipment (PED)
- Medical devices (Directive 93/42/EEC)
- Radio Equipment (RED)
- Electromagnetic compatibility (EMC)
- Medical devices (Regulation 2017/745)
- New Legislative Framework (NLF) and Eco-Management and Audit Scheme (EMAS)
The frameworks associated with indexed references are discovery routes. The product's characteristics and intended use determine which legislation requires examination.