Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

ISO 11608-5:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

07-04-2022

Language(s)

French, English

Published date

20-09-2012

ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.

DevelopmentNote
Supersedes ISO/DIS 11608-5. (09/2012)
DocumentType
Standard
Pages
17
PublisherName
International Organization for Standardization
Status
Superseded
SupersededBy

16/30282706 DC : 0 BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS
DIN ISO 11040-4 E : 2017 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
BS ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
ISO 11608-7:2016 Needle-based injection systems for medical use Requirements and test methods Part 7: Accessibility for persons with visual impairment
I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
I.S. EN ISO 11608-7:2017 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)
13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
DIN EN ISO 11608-7:2015-08 (Draft) NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)
EN ISO 11608-7:2017 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
BS EN ISO 11608-7:2017 Needle-based injection systems for medical use. Requirements and test methods Accessibility for persons with visual impairment
DIN EN ISO 11608-7 E : 2017 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
UNE-EN ISO 11608-7:2018 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
DIN EN ISO 11608-7:2017-10 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)
DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

ISO 11608-4:2006 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 14253-1:2017 Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

View more information
$118.72
Including GST where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more