international iso standard 19979 - specialty and hybrid contact lenses …€¦ · ophthalmic...

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Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lensesOptique ophtalmique — Lentilles de contact — Entretien de l'hygiène

des lentilles de contact d'essai à usage multipatient

INTERNATIONAL STANDARD

ISO19979

First edition2018-03

Reference numberISO 19979:2018(E)

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ISO 19979:2018(E)

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ISO 19979:2018(E)

Foreword ........................................................................................................................................................................................................................................ivIntroduction ..................................................................................................................................................................................................................................v1 Scope ................................................................................................................................................................................................................................. 12 Normative references ...................................................................................................................................................................................... 1

..................................................................................................................................................................................... 14 Methods of hygienic management for multipatient use trial contact lenses ......................................... 25 Options for hygienic management of multipatient use trial contact lenses ........................................... 2

........................................................................................................................................................................................................... 2............................................................................................................................

............................................................................................................................................................................................. 5 ....................................................................................................................................................... 5

6 Flowchart to describe the use of multipatient use trial contact lenses ....................................................... 5Annex A Disinfection procedure using an 3 % ophthalmic hydrogen

peroxide solution ................................................................................................................................................................................................. 7Bibliography ................................................................................................................................................................................................................................ 8

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Contents


ISO 19979:2018(E)

Foreword

www .iso .org/ directives).

www .iso .org/ ).

URL: www .iso .org/ iso/ foreword .html.

Optics and photonics

Ophthalmic optics and instruments.

iv © ISO 2018 – All rights reserved


https://www.iso.org/directiveshttps://www.iso.org/patentshttps://www.iso.org/iso/foreword.html

ISO 19979:2018(E)

Introduction

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Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses

1 Scope

2 Normative references

ISO 18369-1

http:// www .org/

https:// www .iso .org/ obp

3.1trial contact lensdiagnostic contact lens

3.2multipatient use trial contact lens

INTERNATIONAL STANDARD ISO 19979:2018(E)

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ISO 19979:2018(E)

3.3competent personnel

3.4composite contact lens

4 Methods of hygienic management for multipatient use trial contact lenses

in .

5 Options for hygienic management of multipatient use trial contact lenses

5.1 General

2 © ISO 2018 – All rights reserved


ISO 19979:2018(E)

Table 1 — General information

Content Action NOTE1 Precautions

against infections

in persons known to be infected with

— Adenovirus.2 Waste disposal

-

remove the infected lenses from

3 Workbench surface

Hand washingAcanthamoeba.

before the use of gloves. www .who .int/ gpsc/ How _To .pdf.

5 Cleaning of contact lenses before and after

instructions of the

solution.

6 Applicable procedures the methods of disinfection (e.g. lenses. (See ).

7 Number of re-uses or time in use

of use or-

-

-



http://www.who.int/gpsc/5may/How_To_HandWash_Poster.pdfhttp://www.who.int/gpsc/5may/How_To_HandWash_Poster.pdf

ISO 19979:2018(E)

Content Action NOTE8 Re-use of

contact lenses-

9 Contact lens container

-

-

10 Documentation

number of uses.

-

11 Record of each disinfection procedure

-fection.

-

b)records.

12 Storage container labelling

-

5.2 Disinfection procedure with moist heat

Table 1 (continued)



ISO 19979:2018(E)

Table 2 — Disinfection procedure with moist heat (applicable for hydrogel lenses only)

Procedure step ExamplePreparation

Procedure Choice of disinfection process conditions.

5.3 Disinfection procedures using an 3 % ophthalmic hydrogen peroxide for 3 h or equivalent

.

5.4 Storage of disinfected lenses

Table 3 — Storage of disinfected lenses

Step Procedure Information1 Preparation

for storage

tweezers.

processed lenses.b)

2 Duration of storage

3 Wet storage

Dry storage

reuse.

6 Flowchart to describe the use of multipatient use trial contact lenses

See Figure 1.



ISO 19979:2018(E)

Figure 1 — Use of multipatient use trial contact lenses



ISO 19979:2018(E)

Annex A

Disinfection procedure using an 3 % ophthalmic hydrogen

peroxide solution

Table A.1 — Disinfection procedure using an 3 % ophthalmic hydrogen peroxide (H2O2)-solution (applicable for RGP, composite and hydrogel lenses)

Step Procedure Information1 Preparation

2 Procedure

3 Disinfection

procedure.Neutralization

b)



ISO 19979:2018(E)

Bibliography

Ophthalmic optics — Contact lenses and contact lens care products — Determination of

physical compatibility of contact lens care products with contact lenses

Ophthalmic optics — Contact lenses — Determination of shelf-life

Sterilization of health care products — Vocabulary

Ophthalmic optics — Contact lens care products — Microbiological requirements and

test methods for products and regimens for hygienic management of contact lenses

Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices

Sterilization of health care products — Moist heat — Part 1: Requirements for the

development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products — Moist heat — Part 2: Guidance on the

application of ISO 17665-1

34

96 p. 1

127

5

90



ISO 19979:2018(E)

© ISO 2018 – All rights reserved


ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 Methods of hygienic management for multipatient use trial contact lenses5 Options for hygienic management of multipatient use trial contact lenses5.1 General5.2 Disinfection procedure with moist heat5.3 Disinfection procedures using an 3€% ophthalmic hydrogen peroxide for 3 h or equivalent5.4 Storage of disinfected lenses6 Flowchart to describe the use of multipatient use trial contact lensesAnnex€A (informative) Disinfection procedure using an 3€% ophthalmic hydrogen peroxide solutionBibliography

international iso standard 19979 - specialty and hybrid contact lenses …€¦ · ophthalmic...

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