BS ISO 14285-2014 Rubber and plastics gloves for food services Limits for extractable substances《餐饮服务用橡胶和塑料手套 可榨出物质的限制》.pdf

1、BSI Standards PublicationBS ISO 14285:2014Rubber and plastics glovesfor food services Limits forextractable substancesBS ISO 14285:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 14285:2014.The UK participation in its preparation was entrusted to Technical

2、Committee CH/205/3, Medical gloves.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institut

3、ion 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 69660 2ICS 67.250; 83.140.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2014.Amendme

4、nts issued since publicationDate Text affectedBS ISO 14285:2014 ISO 2014Rubber and plastics gloves for food services Limits for extractable substancesGants en caoutchouc et en plastique pour les services alimentaires Limites pour les substances extractiblesINTERNATIONAL STANDARDISO14285First edition

5、2014-02-15Reference numberISO 14285:2014(E)BS ISO 14285:2014ISO 14285:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electroni

6、c or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22

7、 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 14285:2014ISO 14285:2014(E) ISO 2014 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Types . 14 Requirements 24.1 Allowable limits of extractable substances from th

8、e gloves 24.2 Heavy metals . 24.3 Phthalate content 25 Sample preparation . 25.1 Determination of heavy metals . 25.2 Determination of potassium permanganate consumption and the evaporation residue 35.3 Determination of the phthalate content 36 Provision for use . 37 Labelling and marking . 3Annex A

9、 (normative) Determination of heavy metals 4Annex B (normative) Determination of potassium permanganate consumption 8Annex C (normative) Determination of evaporated residue 10Annex D (normative) Determination of phthalate content 12Annex E (informative) Precision 16Bibliography .18BS ISO 14285:2014I

10、SO 14285:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subjec

11、t for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC)

12、 on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be not

13、ed. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying

14、any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of

15、users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Suppleme

16、ntary informationThe committee responsible for this document is ISO/TC 45, Rubber and rubber products, Subcommittee SC 4, Products (other than hoses).iv ISO 2014 All rights reservedBS ISO 14285:2014INTERNATIONAL STANDARD ISO 14285:2014(E)Rubber and plastics gloves for food services Limits for extrac

17、table substancesWARNING Persons using this International Standard should be familiar with normal laboratory practice. This International Standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate saf

18、ety and health practices and to ensure compliance with any national regulatory conditions.1 ScopeThis International Standard specifies limits for extractable chemical substances for single-use gloves made from natural rubber, synthetic rubber, or plastic materials that are intended for use in food p

19、reparation, food handling, and related application in food service industry.This International Standard does not cover the specification for extractable biological substances and physical requirements of the gloves. It is not applicable to gloves used under extreme conditions such as those having pH

20、 less than 4,5 and/or temperature above 40 C. This International Standard does not cover gloves being exposed to fat and oil foods.NOTE The physical requirements specified for gloves could be found in related International Standards, for example, ISO 11193-1 and ISO 11193-2.This International Standa

21、rd does not cover safe and proper application of the gloves with subsequent handling, packaging, and storage procedures.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, onl

22、y the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.EN 14372:2004, Child use and care articles Cutlery and feeding utensils Safety requirements and tests3 TypesGloves are classified into the following types:a) type 1:

23、natural rubber latex;b) type 2: synthetic latex;c) type 3: polyvinyl chloride (PVC);d) type 4: polyethylene (PE);e) type 5: polypropylene (PP).NOTE Gloves made from blend polymer are not covered in this International Standard. ISO 2014 All rights reserved 1BS ISO 14285:2014ISO 14285:2014(E)4 Require

24、ments4.1 Allowable limits of extractable substances from the glovesThe allowable extractable substances for all types of glove shall not exceed the limits presented in Table 1.Determination of the extractable substances shall be carried out according to the test methods given in Table 1.Table 1 Maxi

25、mum limits for allowable extractable substances from food-contact glovesParameters Maximum limit Test methodsHeavy metals, g/ml See Table 2 Annex APotassium permanganate consumption, g/ml10 Annex BEvaporation residue, g/mlDistilled water10 % ethanol100100Annex C4.2 Heavy metalsThe heavy metals shall

26、 not exceed the limits given in Table 2 when tested in accordance with Annex A.Table 2 Limits of heavy metalsElementMaximum limit g/mlArsenic, As 0,05Cadmium, Cd 0,05Chromium, Cr 0,5Lead, Pb 0,5Zinc, Zn 15,04.3 Phthalate contentThe total content of phthalate for Type 3 glove shall not exceed 0,1 % (

27、m/m). The determination of phthalate content shall be carried out as described in Annex D, or in 6.3.2 of EN 14372.5 Sample preparation5.1 Determination of heavy metalsCut one piece of 5 cm 5 cm test sample to provide a surface area of 50 cm2taken from the palm or the back of a glove.The extraction

28、is done by immersing the test piece in a container of 100 ml of the recommended extraction medium. Use water bath to control the temperature, according to the condition given in Table 3.After extraction, remove the test piece from the container and keep the solution for the determination of heavy me

29、tals.2 ISO 2014 All rights reservedBS ISO 14285:2014ISO 14285:2014(E)Table 3 Conditions for sample preparationParameters Extraction medium ConditionsHeavy metals 4 % acetic acid (40 1) C for (10 1) minPotassium permanganate consumption Distilled water (40 1) C for (10 1) minEvaporation residueDistil

30、led water10 % ethanol(40 1) C for (10 1) min5.2 Determination of potassium permanganate consumption and the evaporation resi-dueCut two pieces of 5 cm 5 cm from the palm or the back of gloves to provide a total surface area of 100 cm2. Wash the test samples with distilled water to remove any lubrica

31、nt or powder used to prevent the gloves from sticking together.The extraction is done by immersing the test pieces in a container of 200 ml of the recommended extraction medium. Use water bath to control the temperature, according to the condition given in Table 3.After extraction, remove the test p

32、ieces from the container and keep the solution for the determination of potassium permanganate consumption and the evaporation residue.5.3 Determination of the phthalate contentThe extraction procedure is as described in Annex D, or in EN 14372.6 Provision for use6.1 The manufacturer shall provide i

33、nformation on the provision of the gloves for application in wet or dry conditions.6.2 The glove should remain intact after exposure to wet surfaces throughout the food preparation or handling processes as recommended by the manufacturer.6.3 The glove shall be used only once.7 Labelling and marking7

34、.1 The language used for labelling and marking shall be as agreed upon between the interested parties.7.2 Information provided shall be at the box or packaging container.7.3 Appropriate labelling for food service gloves shall include instructions for use that identify materials or conditions with wh

35、ich contact should be avoided.7.4 Gloves made of natural rubber latex shall be provided with the following label: “Natural rubber latex, which may cause an allergic reaction has been used in the manufacturing of this product”, or words to that effect. ISO 2014 All rights reserved 3BS ISO 14285:2014I

36、SO 14285:2014(E)Annex A (normative) Determination of heavy metalsA.1 PrincipleThis test procedure describes the method for the determination of an individual heavy metal element extracted from gloves using inductively coupled plasma optical emission spectroscopy (ICP-OES). The basis of the method is

37、 the measurement of emission of light by an optical spectroscopic technique. The sample solutions are nebulized and the aerosol that is produced is transported to the plasma torch where the excitation occurs. Characteristic emission spectra are produced by radio frequency inductively coupled plasma

38、(ICP). The spectra are dispersed by a grating spectrometer and the intensities of the lines are monitored by a detector. The signals from the detector(s) are processed and controlled by a computer system. A suitable background correction technique is used to compensate for variable background contri

39、butions to the determination of trace elements.A.2 ApparatusUse usual laboratory apparatus and, in particular, the following.A.2.1 ICP-OES, equipment consisting of sample holder, plasma torch, spray chamber, nebulizer, optical unit, detector, system control, and data output device.NOTE Detailed oper

40、ating instructions is not provided due to the differences between various makers and models.A.2.2 Analytical balance, capable of measuring accurately up to 0,0001 g.A.2.3 Containers, for storage of standard solution and calibrant.NOTE All containers shall be cleaned with 10 % (v/v) nitric acid befor

41、e use.A.2.4 Glassware, all glassware shall be soaked with 10 % (v/v) nitric acid at least 24 h before use.A.2.4.1 Glass beakers, of suitable capacity.A.2.4.2 Volumetric flasks, of suitable size.A.2.4.3 Erlenmeyer flask.A.2.4.4 Pipette.A.2.4.5 Funnel.A.2.5 Micropipettes.4 ISO 2014 All rights reserved

42、BS ISO 14285:2014ISO 14285:2014(E)A.3 ReagentsA.3.1 Argon gas, gas with purity of over 99,99 % (v/v).A.3.2 Nitrogen gas, gas with purity of over 99,99 % (v/v).A.3.3 Nitric acid, (HNO3) = 1,4 g/ml w(HNO3) = 650 g/kg.A.3.4 Deionised water.A.3.5 Nitric acid solution 5 % (v/v), prepare by adding 50 ml o

43、f nitric acid (A.3.3) to deionised water (A.3.4) and bring the volume to 1 000 ml of volumetric flask (A.2.4.2).A.3.6 Standard stock solutions, 100 mg/l of arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), and zinc (Zn).NOTE Standard stock solutions of other concentrations can be used. The stand

44、ard stock solutions can be purchased or prepared from high purity grade chemicals or metals. Traceable standard solutions might be preferred.A.4 Standard solutionsThe following standard solutions for the five elements, i.e. arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), and zinc (Zn) shall be

45、 prepared.A.4.1 Standard solution of 100 g/lPipette 50 l of standard stock solution of the element standard (A.3.6) in a 50 ml volumetric flask. Add 5 % nitric acid solution (A.3.5) to bring the total volume of 50 ml.A.4.2 Standard solution of 500 g/lPipette 250 l of standard stock solution of the e

46、lement standard (A.3.6) in a 50 ml volumetric flask. Add 5 % nitric acid solution (A.3.5) to bring the total volume of 50 ml.A.4.3 Standard solution of 1 000 g/lPipette 500 l of standard stock solution of the element standard (A.3.6) in a 50 ml volumetric flask. Add 5 % nitric acid solution (A.3.5)

47、to bring the total volume of 50 ml.A.5 Laboratory reagent blankThe procedure is identical to that of sample solution preparation and is carried out concurrently but without the sample.A.6 DeterminationA.6.1 GeneralA.6.1.1 Set up the instrument with proper operating parameters established from the ma

48、nufacturers instruction manual. Allow the instrument to achieve thermal stability before beginning. Instructions provided by the manufacturer should be followed.A.6.1.2 Initiate the appropriate operating configuration of the computer. ISO 2014 All rights reserved 5BS ISO 14285:2014ISO 14285:2014(E)A

49、.6.1.3 Profile and calibrate the instrument according to the manufacturers recommended proce-dures using the standard solutions (A.4).A.6.1.4 Begin the sample run by flushing the system with the reagent blank (A.5) between each sam-ple.A.6.2 Recommended wavelengths and important spectral interferencesTable A.1 lists the recommended wavelengths and the important spectral interferences.Table A.1 Recommended wavelengths and the important spectral interferencesElement Wavelength nmInterfering elementsAs