iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN 12218:2000/A1:2002

(Amendment)

Rail systems for supporting medical equipment

Rail systems for supporting medical equipment

Migrated from Progress Sheet (TC Comment) (2000-07-10): TC Res 335/1999: UAP of 4 months (CC/000203)

Schienensysteme zum Halten medizinischer Geräte

Systemes de rails de support pour appareils médicaux

Tračni nosilci za pritrditev medicinske opreme

General Information

Status
Withdrawn
Publication Date
31-Oct-2002
Withdrawal Date
31-Aug-2006
ICS
11.040.99 - Other medical equipment
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Sep-2006
Due Date
01-Sep-2006
Completion Date
01-Sep-2006
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 12218:1998/A1:2002 - Rail systems for supporting medical equipment

Relations

Replaced By
SIST EN ISO 19054:2006 - Rail systems for supporting medical equipment (ISO 19054:2005)
Effective Date
22-Dec-2008
Amends
SIST EN 12218:2000 - Rail systems for supporting medical equipment
Effective Date
22-Dec-2008

Buy Standard

EN 12218:2000/A1:2002EN 12218:2000/A1:2002
PreviousNext
Amendment
EN 12218:2000/A1:2002
English language
2 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12218:2000/A1:2002
01-november-2002
7UDþQLQRVLOFL]DSULWUGLWHYPHGLFLQVNHRSUHPH
Rail systems for supporting medical equipment
Schienensysteme zum Halten medizinischer Geräte
Systemes de rails de support pour appareils médicaux
Ta slovenski standard je istoveten z: EN 12218:1998/A1:2002
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
SIST EN 12218:2000/A1:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 12218:2000/A1:2002

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

SIST EN 12218:2000/A1:2002
EUROPEAN STANDARD
EN 12218:1998/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2002
ICS 11.040; 11.040.99
English version
Rail systems for supporting medical equipment
Systèmes de rails de support pour appareils médicaux Schienensysteme zum Halten medizinischer Geräte
This amendment A1 modifies the European Standard EN 12218:1998; it was approved by CEN on 4 March 2002.
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. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the Management Centre or to any CEN member.
This amendment exists 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
...

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

SIST
SIST EN ISO 22442-2:2021(Main)
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
EN ISO 22442-2:2020

This document specifies requirements for controls on the sourcing, collection, and handling (which
includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing
materials of animal origin other than in vitro diagnostic medical devices. It applies where required by
the risk management process as described in ISO 22442-1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk
management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine
species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production
of medical devices.

  • Standard
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 22442-1:2021(Main)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
EN ISO 22442-1:2020

This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the
residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and
expected medical benefit as compared to available alternatives. This document is intended to provide
requirements and guidance on risk management related to the hazards typical of medical devices
manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a
multiplicity of factors, cannot be set down in such an international standard except for some particular
derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow
derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production
of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture.
However, attention is drawn to international standards for quality management systems (see ISO 13485) that
control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    32 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 23907-1:2019(Main)
Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019)
EN ISO 23907-1:2019

This document specifies requirements for single-use sharps containers intended to hold potentially
hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars,
hypodermic needles and syringes.
It is applicable to single-use sharps containers that are supplied complete by the manufacturer and to
those that are supplied as components intended to be assembled by the user.
It is not applicable to reusable sharps containers or to the outer containers used in the transportation
of filled single-use sharps containers.

  • Standard
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 19054:2006/A1:2017(Amendment)
Rail systems for supporting medical equipment (ISO 19054:2005/Amd 1:2016)
EN ISO 19054:2006/A1:2016

DOW = DAV + 36 months

  • Amendment
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 19054:2006(Main)
Rail systems for supporting medical equipment (ISO 19054:2005)
EN ISO 19054:2006

This International Standard specifies basic requirements to ensure compatibility between rail systems complying with this International Standard and medical equipment in order to facilitate the transfer of medical equipment from one rail system to another. The specifications for rail systems include dimensions, strength and information to be supplied by the manufacturer. This International Standard applies only to rail systems intended to be mounted horizontally. This International Standard does not specify either the structures to which a rail system can be attached or the types of medical equipment that can be supported. This International Standard does not apply to overhead rail systems for supporting curtains and infusion devices.

  • Standard
    31 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO/IEEE 11073-20601:2023(Main)
Health informatics - Device interoperability - Part 20601: Personal health device communication - Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2022)
EN ISO/IEEE 11073-20601:2022

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

  • Standard
    287 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    284 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST-TP CEN ISO/ASTM/TR 52916:2022(Main)
Additive manufacturing for medical - Data - Optimized medical image data (ISO/ASTM TR 52916:2022)
CEN ISO/ASTM/TR 52916:2022

This standard includes creation of optimized data for Medical Additive Manufacturing (MAM) which is
generated from static modalities like Magnetic resonance images (MRI), Computed Tomogram (CT), Positron Emission Tomogram (PET), SPECT and Dynamic modalities like ultrasound and optical image
data. It addresses medical-specific data quality requirements and medical image data acquisition
processing approaches for accurate solid medical models and devices based on real human
information. Also this data can be used for animal surgeries (Veterinary surgery).

  • Technical report
    33 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    31 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN IEC 60601-2-41:2022(Main)
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2021)
EN IEC 60601-2-41:2021

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL
LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This particular standard does not apply to
– headlights;
– endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
– luminaires used in dentistry, which are covered by ISO 9680;
– luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
– luminaires dedicated to therapeutic purposes;
– special purpose lights with different conditions of use such as light sources intended solely
for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps
for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
NOTE See also 4.2 of the general standard.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general
lighting equipment.

  • Standard
    63 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 22442-1:2021(Main)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
EN ISO 22442-1:2020

This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the
residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and
expected medical benefit as compared to available alternatives. This document is intended to provide
requirements and guidance on risk management related to the hazards typical of medical devices
manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a
multiplicity of factors, cannot be set down in such an international standard except for some particular
derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow
derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production
of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture.
However, attention is drawn to international standards for quality management systems (see ISO 13485) that
control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    32 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 22442-2:2021(Main)
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
EN ISO 22442-2:2020

This document specifies requirements for controls on the sourcing, collection, and handling (which
includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing
materials of animal origin other than in vitro diagnostic medical devices. It applies where required by
the risk management process as described in ISO 22442-1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk
management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine
species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production
of medical devices.

  • Standard
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day