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    ISO 11040-2:2011

    Current The latest, up-to-date edition.

    Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  18-03-2011

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11040-2:2011 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for dental local anaesthetic cartridges intended for single use only.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 11040-2. (03/2011)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    00/560909 DC : DRAFT MAR 2000 BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    BS ISO 11040-3:2012 Prefilled syringes Seals for dental local anaesthetic cartridges
    DIN EN ISO 11499:2014-09 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014)
    BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
    BS EN ISO 11499:2014 Dentistry. Single-use cartridges for local anaesthetics
    UNI EN ISO 8871-2 : 2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    10/30216808 DC : 0 BS ISO 11040-3 - PREFILLED SYRINGES - PART 3: SEALS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES
    10/30208782 DC : DRAFT DEC 2010 BS EN ISO 11608-3 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS
    ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
    I.S. EN ISO 11499:2014 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014)
    DIN EN ISO 11499:1999-08 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014)
    13/30257549 DC : 0 BS EN ISO 11499 - DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS
    DIN EN ISO 8871-2:2014-08 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005)
    UNE-EN ISO 11499:2014 Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
    EN ISO 8871-2:2004/A1:2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003/AMD 1:2005)
    I.S. EN ISO 8871-2:2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003)
    UNI EN ISO 11499 : 2014 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS
    ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization
    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
    ISO 11499:2014 Dentistry — Single-use cartridges for local anaesthetics
    EN ISO 11499:2014 Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
    EN ISO 8871-1 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
    PREN ISO 11499 : DRAFT 2013 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO/DIS 11499:2013)
    BS EN ISO 8871-2 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
    ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
    ISO 2230:2002 Rubber products — Guidelines for storage
    ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
    ISO 9997:1999 Dental cartridge syringes
    ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    ISO 11499:2014 Dentistry — Single-use cartridges for local anaesthetics
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    ISO 11040-1:2015 Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges
    ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
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