SIST EN 13060:2005/kprA2:2010

Overview

EN 13060:2004/prA2 (February 2009) is a CEN draft amendment to the European standard EN 13060:2004 - Small steam sterilizers. Prepared by CEN/TC 102, this amendment updates terminology, definitions and a few technical requirements for small steam sterilizers used for medical purposes. The document supports conformity with EC Directives (see informative Annex ZA) and was circulated for CEN enquiry. Scope metadata supplied: 2009-08-04 (EMA: Missing 3-year timeframe added).

Key topics and technical requirements

• Terminology change: All occurrences of “residual air” are replaced by “non‑condensable gases”, clarifying the gases of concern during steam sterilization.
• Definition added: A formal definition of non‑condensable gas - “air and other gas which will not condense under the conditions of steam sterilization” - is introduced into clause 3.
• Pressure definitions updated: Cross‑references in definitions for maximum allowable pressure and operating pressure are amended to cite EN 764‑1:2004 clause numbering.
• Reservoir drainage (Clause 4.7.3.2): The reservoir and associated pipework must be fitted with a valve or other device to allow draining by the operator or the automatic control system - a practical design and maintenance requirement.
• Indicator accommodation (Addition 8.11): A note clarifies that steam indicator strips or devices may be slightly curved but not folded to fit into a 5 mm inner diameter - relevant for biological/chemical indicator holders or packaging.

Practical applications and who uses this standard

This amendment affects the design, manufacture, installation, testing and regulatory compliance of small steam sterilizers used in healthcare and laboratory settings. Typical users include:

• Medical device manufacturers (sterilizer design & documentation)
• Sterile services departments in hospitals (operation and validation procedures)
• Testing and calibration laboratories (performance and safety testing)
• Regulatory and compliance teams (conformity with EC directives and national adoption)
• Procurement specialists specifying sterilizer performance and safety features

Practical impacts include product design adjustments (drain valves, indicator fit), harmonized terminology for validation protocols (focus on non‑condensable gases), and clearer manufacturer instructions for safe operation.

Related standards

• EN 13060:2004 (original small steam sterilizers standard)
• EN 764‑1:2004 (referenced for pressure definitions)
• Informative Annex ZA (relationship with EC Directives)

Keywords: EN 13060, small steam sterilizers, steam sterilization, non‑condensable gases, CEN standard, sterilizer design, medical sterilizers, EN 764-1.