New: Toy Safety Regulation (EU) 2025/2509 — applies from 1 Aug 2030, with digital product passport obligations.

Read the analysis →
Regulation database
EN ISO 11138-3In force

EN ISO 11138-3:2009 — Sterilization of health care products - Biological indicators - Part 3: Moist heat

EN ISO 11138-3:2009Applies from 2011-01-01 SaveOfficial source

Summary

EU MDR harmonised standard EN ISO 11138-3:2009: Sterilization of health care products - Biological indicators - Part 3: Moist heat.

Scope

MDR (Regulation (EU) 2017/745) harmonised standard — Sterilization of health care products - Biological indicators - Part 3: Moist heat.

Expert analysis

Our compliance experts are preparing a detailed analysis for this regulation. Check back soon.

Want this analysis for your product?

Enter your product features once — ComplyMatrix maps all applicable EU regulations, obligations and testing requirements in minutes.