magnifying icon Basket
1 item ^

Basket is empty
Login

Login

LOGGED AS

Help

Satisfaction enquiry

SATISFACTION ENQUIRY

Newsletter

Free of charge lifelong learning "Standardization"

FREE OF CHARGE LIFELONG LEARNING "STANDARDIZATION"

Standardisation

Draft standards in public enquiry

DRAFT STANDARDS IN PUBLIC ENQUIRY

Standards organizations

STANDARDS ORGANIZATIONS

  • National standards

  • European standards

  • International standards


Deliverable

 
Free preview
Price
Language
 
ILNAS-EN ISO 11608-7:2017 Edition 08/2017
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
  •   
  •   
  •   
  •  
  • 40 / copy
  •  
 

Abstract

ISO 11608-7:2016 specifies particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments. It applies to devices intended for patient or caregiver administration of medicinal products to humans. It covers requirements to allow for safe and correct handling of the NIS, including labelling, packaging, and instructions for use. It also includes requirements for training programs, if applicable. It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments. It does not address requirements for use of sharps containers by persons with visual impairments. Although specifically intended to apply to needle-based injection systems within the ISO 11608 series, ISO 11608-7:2016 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments. It is written to address the needs of persons with all levels of visual limitations, including low, moderate, or severe visual impairment; legal, functional, or total blindness; and colour vision deficiencies. Therefore, ISO 11608-7:2016 includes the requirement to provide information in visual formats that can be perceived and understood by people with moderate visual impairment and in non-visual formats (e.g. tactile or auditory) that can be perceived and understood by people with no useful vision. For simplicity's sake, this range is described in ISO 11608-7:2016 as addressing the needs of individuals with moderate visual impairment or blindness.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    18/06/2015   date of ratification (dor)    09/07/2017
end of the vote on the project    18/09/2015   date of anouncement (doa)    30/11/2017
start of the vote on the final project    16/03/2017   date of publication (dop)    28/02/2018
end of the vote on the final project    08/06/2017   date of withdrawal (dow)    28/02/2018


Publication Official Journal
of the Grand-Duchy of Luxembourg
01/02/2018
Reference Mémorial A N° 107

Relations

Relations to international standards
ISO 11608-7 

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

magnifying icon Basket
1 item ^

Basket is empty


Warning:
DIN standards can be downloaded only once! After downloading, they are no longer available in the eLibrary.
Begin download?