Overview
IEC TS 62844:2016 - Guidelines for quality and risk assessment for nano-enabled electrotechnical products is a Technical Specification from IEC TC 113 that gives a recommended methodology for identifying relevant nanomaterial parameters and for implementing generic quality, environment/health/safety (EHS) and risk-assessment measures for nano-enabled or nano-enhanced electrotechnical products. It provides a high-level reference model (not detailed EHS procedures) to support industry adoption, stakeholder communication and the development of product-specific standards.
Key topics and requirements
- Scope and purpose: Recommended methodology for selecting and monitoring parameters of nanomaterials in electrotechnical products and for integrating quality and EHS assessment into product life‑cycle processes.
- Assessment model: A Performance Reference Model (PRM) linking technology measures to customer and business results; measurement indicators and their inter‑relations are emphasized.
- Quality and risk assessment structure: General requirements, assessment model, analysis methods, and risk management process adapted for nano-enabled (NE) products.
- Product-specific considerations:
- Essential performance and expected service life
- Safety and parts that contact persons
- Component-level considerations and general test requirements
- Nanomaterials EHS controls: Guidance on environment, health and safety control measures and special assessment requirements for NE products.
- Quality and risk control: General quality control and risk-control recommendations suitable for industrial mass production.
- Stakeholder documentation and tools:
- Annex B (normative): guidance for stakeholder’s declaration
- Annex C (informative): guidance on correlative indicators and use of House of Quality (HOQ) matrices
- Annex D (informative): steps for manufacturers to compile stakeholder declarations and a standards hierarchy
Applications and who uses it
- Manufacturers and design engineers: to identify critical nanomaterial parameters, establish quality controls, and document EHS considerations for product design and production.
- Quality assurance and EHS managers: to integrate nano-specific risk assessment into existing QA/EHS systems and to prioritize monitoring strategies.
- Standards developers and conformity assessors: as a framework to develop product-specific standards and conformity assessment schemes for nano-enabled electrotechnical products.
- Supply chain and regulatory stakeholders: to improve communication of special requirements and to compile stakeholder declarations for market compliance.
Related standards (if applicable)
- ISO 31000:2009 - Risk management - Principles and guidelines (referenced)
- ISO/TS 80004 series (nanotechnology terminology) and ISO 14001 (environmental management) are relevant context standards cited in the TS.
Keywords: IEC TS 62844:2016, nano-enabled electrotechnical products, nanomaterials, quality and risk assessment, EHS control, stakeholder’s declaration, Performance Reference Model, House of Quality.