SIST EN 13060:2015/oprA1:2018

Small steam sterilizers

This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE   Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665 1.
This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

Dampf-Klein-Sterilisatoren

Petits stérilisateurs à la vapeur d'eau

Mali parni sterilizatorji

General Information

• Status: Not Published
• Public Enquiry End Date: 09-Jan-2018
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 06-Dec-2018
• Due Date: 11-Dec-2018
• Completion Date: 06-Dec-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 13060:2014/prA1:2017 - Small steam sterilizers

Relations

• Consolidated By: SIST EN 13060:2015+A1:2019 - Small steam sterilizers
• Effective Date: 18-Jan-2023
• Amends: SIST EN 13060:2015 - Small steam sterilizers
• Effective Date: 01-Jan-2018

Overview

EN 13060:2014/prA1:2017 is the European standard that defines performance requirements and test methods for small steam sterilizers used for medical purposes or for materials likely to contact blood or body fluids. It applies to automatically controlled small steam sterilizers that either generate steam with electrical heaters or are fed from an external steam source. The standard targets sterilizers with a chamber volume < 60 L and that cannot accommodate a sterilization module sized 300 × 300 × 600 mm. The 2017 draft amendment (prA1) adds transitional provisions for legacy models using the “4 K band.”

Key topics and requirements

• Scope & applicability: Small, automatically controlled steam sterilizers for medical devices; excludes sterilizers for liquids or pharmaceutical products.
• Performance requirements: Criteria that sterilizers must meet in terms of sterilization effectiveness, repeatability and cycle control (high level - see standard for specifics).
• Test methods: Standardized tests for verifying sterilizer performance, cycle parameters and control systems.
• Sterilization cycles: Definition and classification of cycles intended for medical device processing and items likely to contact body fluids.
• Design constraints: Chamber volume limit (< 60 L) and module accommodation criterion (cannot accept 300 × 300 × 600 mm modules).
• Steam generation: Coverage of both integral electric-heated steam generation and sterilizers supplied with external steam.
• Exclusions & limits: Does not cover validation/routine control of moist heat sterilization (see EN ISO 17665), safety hazards from the use environment (e.g., flammable gases), or other moist-heat-containing processes (e.g., ethylene oxide/formaldehyde).
• Transitional provisions: Amendment prA1 allows continued market supply of pre-existing models supplied with the earlier “4 K band” specification.

Practical applications

• Use for procurement, design and testing of small steam sterilizers in:
  • Dental and outpatient clinics
  • General practitioner offices and small hospitals
  • Veterinary surgeries and laboratories
  • Medical device manufacturers designing compact sterilizers
• Useful to manufacturers, test laboratories, clinical engineers, sterilization technicians and quality/regulatory teams to ensure equipment meets European performance expectations before placing on the market.

Related standards

• EN ISO 17665 - Validation and routine control of moist heat sterilization (validation guidance)
• EN ISO 13485 - Quality management systems for medical devices
• EN ISO 14971 - Application of risk management to medical devices
• Annex ZA of EN 13060 links the standard to relevant EU directives and regulatory requirements.

Keywords: EN 13060, small steam sterilizers, steam sterilizer standard, medical device sterilization, performance requirements, test methods, chamber <60 L, EN ISO 17665.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2018
Mali parni sterilizatorji
Small steam sterilizers
Dampf-Klein-Sterilisatoren
Petits stérilisateurs à la vapeur d'eau
Ta slovenski standard je istoveten z: EN 13060:2014/prA1:2017
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
EN 13060:2014
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
November 2017
ICS 11.080.10
English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau Dampf-Klein-Sterilisatoren
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 102.

This draft amendment A1, if approved, will modify the European Standard EN 13060:2014. If this draft becomes an amendment,
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration.

This draft amendment was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

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