iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN ISO 15253:2001/AC:2001

(Amendment)

Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)

Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)

CMC - Wrong ICS number

Augenoptik und ophthalmische Instrumente - Vergrößernde Sehhilfen für Sehbehinderte (ISO 15253:2000)

Optique et instruments ophtalmiques - Dispositifs optiques pour malvoyants (ISO 15353:2000)

Očesna optika in instrumenti - Optične naprave za izboljšanje slabovidnosti (ISO 15253:2000)

General Information

Status
Withdrawn
Publication Date
31-Oct-2001
Withdrawal Date
20-Jul-2021
ICS
11.040.70 - Ophthalmic equipment
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
21-Jul-2021
Due Date
13-Aug-2021
Completion Date
21-Jul-2021
Ref Project
EN ISO 15253:2000/AC:2001 - Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)

Relations

Replaced By
SIST EN ISO 15253:2021 - Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021)
Effective Date
01-Sep-2021
Corrects
SIST EN ISO 15253:2001 - Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)
Effective Date
22-Dec-2008
Corrects
SIST EN ISO 15253:2001 - Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)
Effective Date
08-Jun-2022

Buy Standard

EN ISO 15253:2001/AC:2001EN ISO 15253:2001/AC:2001
PreviousNext
Corrigendum
EN ISO 15253:2001/AC:2001
English language
2 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik und ophthalmische Instrumente - Vergrößernde Sehhilfen für Sehbehinderte (ISO 15253:2000)Optique et instruments ophtalmiques - Dispositifs optiques pour malvoyants (ISO 15353:2000)Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 15253:2000/AC:2001SIST EN ISO 15253:2001/AC:2001en01-november-2001SIST EN ISO 15253:2001/AC:2001SLOVENSKI
STANDARD



SIST EN ISO 15253:2001/AC:2001



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 15253:2000/ACMarch 2001Mars 2001März 2001English versionVersion FrançaiseDeutsche FassungOphthalmic optics and instruments - Optical devices for enhancing lowvision (ISO 15253:2000)Optique et instruments ophtalmiques -Dispositifs optiques pour malvoyants (ISO15353:2000)Augenoptik und ophthalmische Instrumente- Vergrößernde Sehhilfen fürSehbehinderte (ISO 15253:2000)This corrigendum becomes effective on 7 March
...

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 19979:2023(Main)
Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial contact lenses (ISO 19979:2018)
EN ISO 19979:2023

ISO 19979:2018 provides guidance to manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial hydrogel, composite and rigid gas-permeable (RGP) contact lenses intended for multipatient use.
ISO 19979:2018 does not apply to:
-      labelling of contact lenses;
-      the inactivation of prions and viruses since there are no standardised methods available for contact lenses.
ISO 19979:2018 can be used as guidance for the development of a hygienic management procedure for multipatient use.
NOTE       ISO 14729 does not cover multipatient use.

  • Standard
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10943:2023(Main)
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
EN ISO 10943:2023

This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
This document is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.

  • Standard
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 8980-3:2022(Main)
Ophthalmic optics - Uncut finished spectacle lenses - Part 3: Transmittance specifications and test methods (ISO 8980-3:2022)
EN ISO 8980-3:2022

This document specifies requirements for the transmittance properties of uncut and unmounted
finished spectacle lenses, including attenuation of solar radiation.
This document is not applicable to
— spectacle lenses having specific transmittance or absorption characteristics prescribed for medical
reasons,
— products to which specific personal protective equipment transmittance standards apply, and
— products intended for direct observation of the sun, such as for solar-eclipse viewing.
NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles.
NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980-1
and ISO 8980-2, and for mounted lenses, in ISO 21987.

  • Standard
    42 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 10942:2022(Main)
Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)
EN ISO 10942:2022

This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test
methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus.
This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

  • Standard
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 15798:2022(Main)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
EN ISO 15798:2022

This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive
medical devices with viscous and/or viscoelastic properties, intended for use during surgery in
the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect
intraocular tissues and to manipulate tissues during surgery.
This document specifies requirements with regard to safety for the intended performance, design
attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and
information supplied by the manufacturer of these devices.

  • Standard
    27 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 16672:2021(Main)
Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
EN ISO 16672:2021

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical
devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the
retinal pigment epithelium (RPE), or to tamponade the retina.
With regard to the safety and efficacy of OE, this document specifies requirements for their intended
performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging,
product labelling and the information supplied by the manufacturer.

  • Standard
    23 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 15253:2021(Main)
Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021)
EN ISO 15253:2021

This document is applicable to optical and electro-optical devices specified by the manufacturer for
use by visually impaired persons as low vision aids. This document specifies requirements and test
methods for optical and electro-optical devices specified by the manufacturer for use by visually
impaired persons as low vision devices.
Implantable low vision devices are excluded.

  • Standard
    35 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 19980:2021(Main)
Ophthalmic instruments - Corneal topographers (ISO 19980:2021)
EN ISO 19980:2021

This document specifies minimum requirements for instruments and systems that fall into the class of
corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument
complies with this document and thus qualifies as a CT according to this document. It also specifies
tests and procedures that allow the verification of capabilities of systems that are beyond the minimum
requirements for CTs.
This document defines terms that are specific to the characterization of the corneal shape so that they
may be standardized throughout the field of vision care.
This document is applicable to instruments, systems and methods that are intended to measure the
surface shape of the cornea of the human eye.
NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional
topographical measurements of the surface or other more global parameters used to characterize the surface.
This document is not applicable to ophthalmic instruments classified as ophthalmometers.

  • Standard
    29 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 15004-1:2021(Main)
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
EN ISO 15004-1:2020

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers,
but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11979-5:2020(Main)
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
EN ISO 11979-5:2020

This document specifies particular requirements for the biocompatibility evaluation of materials for
intraocular lenses (IOLs) including the processing conditions to produce them. These requirements
include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives
guidance on conducting an ocular implantation test.

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