iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 9187-1:1999

(Main)

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:1999)

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:1999)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Sweden has made an A-deviation request (see fax upstone) GDJ 1997-10-07 ++ TC letter of 98-04-07 to GDJ:held static bec. overlap between CEN & EPC (TA/9804 ++ 10)

Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:1999)

Diese Internationale Norm legt Werkstoffe, Maße, den Inhalt und Anforderungen an drei Formen von Ampullen aus Glas (Formen B,C und D) für Injektionspräparate fest. Diese Internationale Norm gilt für Ampullen ohne und mit Farbbrechring. Wenn Ampullen mit Farbbrechring vom Anwender verlangt werden, sollte dies, einschließlich der Farbe des Farbbrechringes, zwischen Hersteller und Anwender vereinbart werden. Ampullen entsprechend dieser Internationalen Norm sind nur zur einmaligen Verwendung bestimmt.

Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:1999)

Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne farmacevtske oblike (ISO 9187-1:1999)

General Information

Status
Withdrawn
Publication Date
16-Feb-1999
Withdrawal Date
27-May-2003
ICS
11.040.01 - Medical equipment in general
Technical Committee
CEN/SS S02 - Transfusion equipment
Drafting Committee
CEN/SS S02 - Transfusion equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
28-May-2003
Completion Date
28-May-2003
Ref Project
SIST EN ISO 9187-1:2000 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:1999)

Relations

Corrected By
EN ISO 9187-1:1999/AC:1999 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:1991)
Effective Date
22-Dec-2008
Replaced By
EN ISO 9187-1:2003 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2000)
Effective Date
22-Dec-2008

Buy Standard

EN ISO 9187-1:2000EN ISO 9187-1:2000
PreviousNext
Standard
EN ISO 9187-1:2000
English language
7 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9187-1:2000
01-januar-2000
Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne
farmacevtske oblike (ISO 9187-1:1999)
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:1999)
Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für
Injektionspräparate (ISO 9187-1:1999)
Matériel d'injection a usage médical - Partie 1: Ampoules pour produits injectables (ISO
9187-1:1999)
Ta slovenski standard je istoveten z: EN ISO 9187-1:1999
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 9187-1:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 9187-1:2000

---------------------- Page: 2 ----------------------

SIS
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 14971:2019/A11:2021(Amendment)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
SIST EN ISO 14971:2020/A11:2022

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

  • Amendment
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 13485:2016/A11:2021(Amendment)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
SIST EN ISO 13485:2016/A11:2021
  • Amendment
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Amendment
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 15223-1:2021(Main)
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
SIST EN ISO 15223-1:2021

This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

  • Standard
    63 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    48 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 20417:2021(Main)
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
SIST EN ISO 20417:2021

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

  • Standard
    81 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    81 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    82 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TR 20416:2020(Main)
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
SIST-TP CEN ISO/TR 20416:2020

This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities. The output of this process can be used:
—     as input into product realization;
—     as input into risk management;
—     for monitoring and maintaining product requirements;
—     for communicating to regulatory authorities; or
—     as input into improvement processes.
This document does not address market surveillance activities to be performed by regulatory authorities. Neither does it specify a manufacturer's actions required by the applicable regulatory requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.

  • Technical report
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    49 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TR 24971:2020(Main)
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
SIST-TP CEN ISO/TR 24971:2020

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25].

  • Technical report
    96 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    92 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13718-1:2014+A1:2020(Main + Amendment)
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
SIST EN 13718-1:2015+A1:2020

This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions. This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.

  • Standard
    18 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13718-2:2015+A1:2020(Main + Amendment)
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
SIST EN 13718-2:2015+A1:2020

This part of EN 13718 specifies the requirements for performance and equipping for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least one person on a stretcher.
NOTE   Requirements are specified for categories of air ambulances based on the different intended use. These are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and the fixed wing air ambulance (FWAA).

  • Standard
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 14971:2019(Main)
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
SIST EN ISO 14971:2020

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
—          decisions on the use of a medical device in the context of any particular clinical procedure; or
—          business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE       Guidance on the application of this document can be found in ISO/TR 24971[9].

  • Standard
    46 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard – translation
    44 pages
    Slovenian language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    51 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 13485:2016/AC:2018(Corrigendum)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
SIST EN ISO 13485:2016/AC:2018

CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear

  • Corrigendum
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day