ISO 7886-1:2017
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- Standard No.
- ISO 7886-1:2017
- Release Date
- 2017
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 7886-1:2017/Amd 1:2019
- Latest
- ISO 7886-1:2017/Amd 1:2019
- Scope
- This document specifies requirements and test methods for verifying the design of empty sterile single- use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.
ISO 7886-1:2017 Referenced Document
- IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 14971:2007 Medical devices - Application of risk management to medical devices
- ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
- 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 384:2015 Laboratory glass and plastics ware - Principles of design and construction of volumetric instruments
- ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
- ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO 7886-1:2017 history
- 2019 ISO 7886-1:2017/Amd 1:2019 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- 2017 ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- 1995 ISO 7886-1:1993/cor 1:1995 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use; Technical Corrigendum 1
- 1993 ISO 7886-1:1993 Sterile hypodermic syringes for single use; part 1: syringes for manual use
