SIST EN 455-2:2010/kFprA1:2010
(Amendment)Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medical gloves for single use - Part 2: Requirements and testing for physical properties
This Amendment provides an updated Table 3 "The median values of force at break" to minimize the possible interpretation and misunderstandings regarding the values given in the appropriate table of EN 455-2:2009.
Scope of the mother text:
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften
Gants médicaux non réutilisables - Partie 2: Propriétés physiques: Exigences et essais
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnosti - Dopolnilo
General Information
- Status
- Not Published
- Public Enquiry End Date
- 14-Nov-2010
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 98 - Abandoned project (Adopted Project)
- Start Date
- 24-Feb-2011
- Due Date
- 01-Mar-2011
- Completion Date
- 24-Feb-2011
Relations
- Consolidated By
SIST EN 455-2:2010+A1:2011 - Medical gloves for single use - Part 2: Requirements and testing for physical properties - Effective Date
- 01-Jul-2011
- Effective Date
- 01-Nov-2010
Overview
EN 455-2:2009/FprA1 is a CEN draft amendment to the European Standard EN 455-2:2009 addressing physical properties and testing of single-use medical gloves. The amendment specifically replaces and clarifies Table 3 - the median values of force at break - to reduce misinterpretation and ensure consistent application across surgical and examination/procedure gloves. The underlying standard aims to ensure that single-use gloves provide and maintain adequate protection from cross-contamination for both patient and user.
Key Topics
- Scope and purpose: Clarification of median force-at-break requirements for different glove materials and types, improving harmonised testing and reporting.
- Revised Table 3 values: The amendment provides explicit median force-at-break thresholds differentiated by glove type and material category, and indicates applicability when tested throughout shelf life (per clause 5.2) and within 12 months of manufacture (per clause 5.3).
- Material categories: Table 3 identifies categories (a) to (e) and links them to materials, such as:
- a) Natural rubber latex
- b) Other elastomeric materials (polychloroprene, synthetic polyisoprene, nitrile, styrene block copolymers, polyurethane)
- c) Elastomeric materials except nitrile (natural rubber latex, polychloroprene, synthetic polyisoprene, styrene block copolymers, polyurethane)
- d) Nitrile
- e) Thermoplastic materials (PVC, polyethylene)
- Testing clarity: By replacing the existing table, the amendment reduces ambiguity about which median values apply for a given glove construction and test timing.
Applications
This amendment and the parent standard EN 455-2 are directly relevant to:
- Manufacturers of surgical gloves and examination/procedure gloves implementing physical property testing and quality control routines.
- Quality and regulatory teams ensuring compliance with European medical device standards and documenting conformity for market placement.
- Test laboratories performing force-at-break and tensile testing to specified median values and reporting results consistently.
- Procurement and clinical risk managers who rely on standards-based specifications to select single-use gloves that deliver reliable protection.
Practical benefits include clearer test acceptance criteria, reduced disputes over interpretation of median values, and improved traceability of test results through product shelf life. Note that EN 455-2 does not set a lot size but highlights practical control issues; a recommended maximum individual lot size for production is 500 000.
Related Standards
- EN 455-1: Requirements and testing for freedom from holes (integrity)
- EN 455-3: Ageing of single-use medical gloves and related requirements
- EN 455-4: Determination of shelf life
For implementers, aligning testing protocols with EN 455-2:2009/FprA1 helps ensure consistent measurement of force at break, correct material categorisation, and better protection outcomes for patients and users.
Frequently Asked Questions
SIST EN 455-2:2010/kFprA1:2010 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical gloves for single use - Part 2: Requirements and testing for physical properties". This standard covers: This Amendment provides an updated Table 3 "The median values of force at break" to minimize the possible interpretation and misunderstandings regarding the values given in the appropriate table of EN 455-2:2009. Scope of the mother text: This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
This Amendment provides an updated Table 3 "The median values of force at break" to minimize the possible interpretation and misunderstandings regarding the values given in the appropriate table of EN 455-2:2009. Scope of the mother text: This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
SIST EN 455-2:2010/kFprA1:2010 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 455-2:2010/kFprA1:2010 has the following relationships with other standards: It is inter standard links to SIST EN 455-2:2010+A1:2011, SIST EN 455-2:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 455-2:2010/kFprA1:2010 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 455-2:2010/kFprA1:2010 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2010
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za
ugotavljanje fizikalnih lastnosti - Dopolnilo
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und
Prüfung der physikalischen Eigenschaften
Gants médicaux non réutilisables - Partie 2: Propriétés physiques: Exigences et essais
Ta slovenski standard je istoveten z: EN 455-2:2009/FprA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
FINAL DRAFT
EN 455-2:2009
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
September 2010
ICS 11.140
English Version
Medical gloves for single use - Part 2: Requirements and testing
for physical properties
Gants médicaux non réutilisables - Partie 2: Propriétés Medizinische Handschuhe zum einmaligen Gebrauch - Teil
physiques: Exigences et essais 2: Anforderungen und Prüfung der physikalischen
Eigenschaften
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 205.
This draft amendment A1, if approved, will modify the European Standard EN 455-2:2009. 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments
...
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