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Coversheet
Document Number: E302

Revision: AW

Document Title: PALL GLOBAL PROCUREMENT SPECIFICATION

FOR O-RING SEALS WITH CONTROLLED
COMPOUNDS
Pall关于
关于含
关于含受控化合物的
受控化合物的Ｏ型密封圈的全球采购规范
型密封圈的全球采购规范

Document Type: SPECIFICATION

Document Owner: Pall Industrial – Advanced Engineering (Cortland)

Copyright © 2008 PALL CORPORATION CONFIDENTIAL

This document may contain confidential technical date, including trade secret proprietary to Pall
Corporation. The document design rights and all other disclosures in this document are the property of
Pall Corporation. Unauthorized use, copying, distribution to third parties ,manufacture, or reproduction in

本文件可能包含属于颇尔公司所有权的技术保密和商业保密信息。其图纸、设计版权和此文件中所有
whole or in part is prohibited.

其他公布的信息均为颇尔公司所有版权。未经授权不得使用、拷贝、分发到第三方，也不得生产或复
制其全部或部分内容。

电子版本受控文件：使用前请确认文件受控状态。
Electronically Controlled Document: Please confirm control status before use

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I Application 范围：
This specification covers the requirements for the manufacture and inspections procedures for all
seals referenced herein.
本规范涵盖了以下所条款提到的密封圈在制造和检验过程中的要求。
II Regulatory Requirements 法规要求：

A The following application codes and regulatory requirements are invoked as required in
Appendix B. Pall shall determined suitability based on supplier data review as well as in-house
product testing.
以下使用的代号和法规要求因为在附件 B 中引用而生效。Pall 可以基于供应商的数据审核和内部
的产品测试决定其适用性。
“E”- compounds for electronic grades applications.
“E”适用于电子级应用的材料。
“L”- Low durometer compounds (less than or equal to 50 durometer) required to facilitate ease of
installation and removal of end product.
“L”低硬度化合物（50，硬度计计量），在终产品上要易于安装或去除。
“P”- compounds that are suitable for pharmaceutical applications and comply with Code of
Federal Regulations, Title 21, Section 177.2600 all Subparts and pass USP Class VI at 121oC
testing requirements. See Paragraph II.B.
“P”适用于制药领域的化合物，符合FDA 21CFR 177.2600所有的条款及附加条款且通过121℃下USP
VI级的要求。详见II B。
“W”– compounds that are suitable for Food and Beverage, for non oily and oil food contact use.
Supplier letter certifying compliance to all applicable standards must be on file with industrial
QA/RA.
“W”适用于食品饮料行业的化合物，用于无油及无油质的食品接触。供应商对所有应用标准的符
合书面声明应和QA/RA文件一起存档。
（1） Requires compliance with 3A Dairy Standards No. 18-00. Class to be defined in
Appendix B.
要求符合3A乳制品标准18-00。按照附件B分类。
（2） Code of Federal Regulations Title 21, Section 177.2600 all Subparts.
FDA 21CFR 177.2600的所有条款。
（3） European Regulation 327/2007/EC, plus EU Regulation 1935/2004/EC and Directive
93/11/EEC– and if considered a plastic, requires compliance with appropriate sections
of EU Directive 2002/72/EC and it’s amendments.
欧洲指令 372/2007/EC 加欧盟法规 1935/2004/EC，指令 93/11/EEC。如果是塑料，要求
符合欧盟指令 2007/72/EC 及其修正案。
（4） Requires compliance to Pall Specification E962 relating to disallowed and controlled
substances.
符合Pall E962 关于控制和限制的物质规定的要求。

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“W1” - compounds that are suitable for Food & Beverage. As “W” but for non oily food
contact only, not suitable for use in milk or edible oils.supplier letter certifying
compliance to all applicable standards must be on file with industrial QA/RA
适用于食品饮料行业的化合物。和“W”类似，但是只用于无油食品接触，不适用
于牛奶和食用油。供应商书面声明应和工业QA/RA一起存档。
“W3” – compounds that are suitable for Food and Beverage in Japan. Requires
compliance to Japanese food regulations as detailed in specifications and
standards for foods, food additives, etc. under the Food Sanitation Law. Supplier
letter certifying compliance to all applicable standards must be on file with
适用于日本的食品饮料行业的化合物。要求符合日本食品法中日
industrial QA/RA.
本食品法规对于食品、食品添加剂等的规定和标准。对所有应用标准的符合纸面声
明应和QA/RA一起存档。
“U”- compound may only be used for housing seals.
“U”可能仅适用于滤壳密封的化合物。
B The following option codes have specific regulatory requirements.
下列选项的代号有特定的法规要求：
J4- Ethylene propylene for drinking water usage/ Requires:
乙烯丙烯（单体/橡胶），应用于饮用水。要求如下：
NSF Certified to standards 53 and 61
NSF声明的标准53和61。
•

• Certification by the French Health Ministry based on LHRSP testing. Manufacture from
material in compliance with FDA requirements for food contact use as detailed in
21CFR177.2600.
法国健康部基于LHRSP测试的声明。制造的材料要符合FDA对于食品接触材料的规定中的
21CFR 177.2600的要求。
• Water Regulations Advisory Scheme (WRAS) approval. Must be listed in the water
fittings and materials directory for cold and hot water use up to 85 degrees C – which
includes fittings, material and appliances approved for use on the UK Water Supply
System.
水法规计划委员会（WRAS）许可。这些材料和装置必须列于可用于85℃以下冷热水的装置
和材料目录上。
• Testing to the requirements of KTW (Kunstoff Trinkwasser-Empfehlungen
recommendations for plastics and other non metallic materials which are intended for use
in contact with drinking water issued by the German Federal Health Office).
按照KTW要求进行测试（Kunstoff Trinkwasser Empfehlungen推荐用于德国食品健康局规
定的饮用水塑料盒非金属材料）。
H31A- Nitrile elastomer for portable water. Requirements：
适用于水的腈橡胶H31A，要求如下：
• Water Regulations Advisory Scheme (WRAS) approval for use in hot and cold waters.
水法规计划委员会（WRAS）对于用于热水和冷水的许可。
• NSF 61, section 6 certification.
NSF 61,第6段的证明。
• Dairy standard for milk and butter oil class 3A.
关于牛奶和黄油3A级的奶制品3A标准。
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H27- Silicone for drinking water usage. Requires:

适用于饮用水的硅橡胶H27，要求如下：
• Water Regulations Advisory Scheme (WRAS) APPROVAL. Must be listed in the water
fittings and materials directory for cold and hot water use up to 85 degrees C - which
includes fittings, material and appliances approved for use on the UK Water Supply
System.
有水法规计划委员会（WRAS）的许可，且必须列于可以在冷水和高达85℃的热水中使用的
配件和材料目录。包括用于英国水供应系统的配件、材料和用具。
• Manufacture from material in compliance with FDA requirements with food contact use as
detailed in 21CFR177.2600.
制造的材料要符合FDA对于食品接触的21CFR177.2600的要求。
H33-Silicone elastomer originally set up for NPL Beer Market.
H33-硅材料，通常用于日本的啤酒市场
C When regulatory requirements of Section II.A are invoked on compounds identified in Appendix
B, it is the supplier’s responsibility to certify compliance. In some cases, with some compounds,
Pall has undertaken testing and has documented the compound’s compliance with certain
regulations (i.e. such as USP Class VI at 121 degrees C). In these cases, Appendix B will indicate
that Pall has obtained the appropriate certification. The supplier will be relieved of the
requirement(s) and needs only to certify to the remaining regulatory and specification requirements.
当附件 II A 中规定的要求被在附件 B 中定义的化合物引用时，供应商须负责提供符合性证明。在某
些情况下，对于某些化合物，Pall 承担测试的责任以及提供对于特定法规的符合文件（例如，USP
VI 级 121℃）。在这种情况下，附件 B 将表明 Pall 已经获得了相应的声明。供应商将被免除此项
义务，而只需要证明符合剩下的规定和标准要求。
D New compound qualification
新化合物资格
Substituting for, or adding new compounds to those approved by pall corporation( advanced
engineering –Cortland) as being in compliance to this specification ,is not permissible without Pall
approval. Alternative compounds shall be considered only if there is an economic need,
performance or availability issue to justify expenditure of Pall resources to qualify these alternate
compounds. Pall product design authorities must be involved in and approve in writing any
compound change or addition. The need for regulatory requirements must be reviewed and
letters of compliance obtained for Pall’s QC file.
若无 Pall 的许可，不得替代、增加新化合物到这份标准定义的化合物中。只有出于需要调整 Pall
资源消耗的经济、性能和适用性时，可以考虑选用合格所谓替代性化合物。Pall 的产品设计部门
必须在书面被涉及并批准化合物变更和添加。规定要求的需要必须被审查并且 Pall 的 QC 文档中必
须存在符合性通知。
III Physical Characteristics of O rings
O型圈的物理性质
A. Dimensions must be in accordance with those listed in the latest revisions of SAE AS568,
united Kingdom BS ISO 3601, or drawing if referenced on the purchase order.
尺寸必须和最新版的 SAEAS568，英国 BS ISO 3601 所列的一致，或者与订单的图纸一致。
B. Any visible imperfections must be within the maximum acceptable per BS ISO 3601-3:2005
and the Rubber Manufactures Association (RMA) Handbook, Category “B” with a 2.5 AQL.

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Visible imperfections are described in general in the RMA Handbook.
任何可视的缺陷必须是在 BS ISO 3601-3：2005 最大接受范围内和满足橡胶制造协会手册分类
B 2.5 的抽样水平。目测缺陷的概括描述在 RMA 手册中。
C. Moulding flash and voids to be controlled in accordance with MIL STD 413C or BS ISO3601-
2005 模具更新或报废的控制参照 MIL STD 413C 或 BS ISO 3601-3：20065 要求。
D. Part numbering, elastomeric compounds, curing system and colour must be in accordance
with Appendix B or drawing if referenced on the purchase order.
料号、橡胶化合物、固化系统和颜色必须和附录 B 或采购订单的图纸要求一致。
E. Parts must be packaged immediately upon completion of manufacturing process to prevent
excessive atmospheric contamination.
制造完成后应立即包装，以避免过度的大气污染。
IV. Cleanliness 清洁
:
A. It is understood that some elastomers cannot be molded or extruded without the use of a
mold/die release agent. It is Pall’s preference that mold/die release agent is not used
whenever possible. Mold/die release agents are allowed only if all of the following conditions
are met.
一般认为某些弹性橡胶如不使用模/金属模脱模剂就无法成型或挤出成材。在任何时候 Pall 都
会偏向不使用模/金属模脱模剂。只有在符合以下条件时才允许使用模/金属模脱模剂：
1. Supplier must provide Pall the mold/die release agent composition for review and
approval prior to its use.
供应商应在使用模/金属模脱模剂前提供其化学成分给 Pall 审核和批准。
2. Any mold/die release agent composition used must be fully soluble in, and washed off by
using clean water in such a manner that it will remove the release agent. Seal to be dried
in a clean air environment.
任何一种膜/金属模脱模剂都必须完全溶于清水，并可以用清水冲洗清除密封圈应在干净的
空气环境中干燥。
B. All seals - no matter how manufactured (i.e. molded, extruded, lathe cut, steel rule die cut etc)
– are to be washed in clean water such that manufacturing debris is removed, then dried.
所有的密封圈-无论是如何制造的（例如：倒模、挤出、车床切割、钢尺模切等）都要用清水
洗去制造过程中产生的碎屑，并干燥。
-
C. Foreign materials including (but not limited to) the following are not permitted: dirt,
grease, oil, lubricants, silicone, inks, cardboard fragments, paper, cross -contamination
from surrounding processes / previous non-controlled runs.
不允许存在的异物包括（但不限于）：污垢、油脂、油、润滑剂、硅、油墨、纸板碎片、纸以
及周边工序或前道为控制的工序的 交叉污染。
D. If secondary operations (such as machining) are required, no cutting lubricants are to
be used. Equipment must be cleaned prior to machining of items.
如果需要二次加工（如机加工），不能使用切削润滑剂。加工前必须先清洗设备。
E. Holding fixtures for secondary operations must not contribute to part contamination
and must be made from corrosion resistant materials.
二次加工所使用的家具不得造成产品污染并且必须是由防腐材料制成的。

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V. Packaging 包装
A. As this specification is intend for Pall Corporate global use, packing and shipment
requirements may vary depending on manufacturing site placing the order, site-specific
requirements will be indentified.
在这份规范成为 Pall 公司全球使用时，包装和运输的要求可能会随着制造厂的订单不同而有
所改变。不同地区的具体要求要专门表明。
B. Each shipment must be accompanied by a completed “Certificate of Compliance”.
Certificate to include:每一批货都应附带一个完整的 “符合性证书”（COC）
证书包括：
Purchaser’s Part Number 采购料号 Durometer 硬度
Purchaser’s Purchase Order Number Manufacturer’s Name 制造商名称
购买方的采购订单号
Lot Number 批号 Quantity 数量
Elastomeric Compound Number Date of Manufacture 生产日期
弹性橡胶化合物编号
Shelf life expiration date (if applicable) 保存期限（如有可能）
Acknowledgement of compliance to the regulatory requirements specified in Section II.
Note allowable exception explained in Section II.C.
关于符合性法规的要求的内容见 II 部分。豁免注释在 II 段的 C 中。
One copy of the controlled “Certificate of Compliance” is to be enclosed with every
shipment of seals.
每一批的密封圈都应附带一份完整的 “符合性证书”的复印件。
C. Bags to be sealed in a manner which allows and resealing without damage to bags.O-rings
shall be sealed in double plastic bags to maintain component cleanliness, and overpacked in
protective boxes to prevent damage in shipment.
密封的袋子应该是可以无损坏的重复打开和封闭的。O 型圈应该密封在双层熟料袋中以保持组
件洁净，然后再放入防护纸箱中防止在运输途中损坏。
D. Each shipment of O-rings shall originate from a single lot (batch, run) of elastomeric
compound if possible. If this is not possible, each distinct lot of material shall be packaged
separately and clearly identified per Section V.E of this specification. Lots may not be mixed
in shipping cases or containers.
如有可能，按照弹性橡胶化合物的单独的批号（批次，流水线）区分每一批 O 型圈。如果不能
实现，按照本规范的 VE 段要求在将每一个批号的材料单独包装并清楚标示。货运箱和货柜的
批号不能混淆。
E. Each box and inner bag of O-rings shall be indelibly identified with the following information:
O 型圈的每一个纸箱及其内袋上应标识以下内容（标示不能内轻易清除）：
Purchaser’s part number and material 购买者的料号和材质
Lot number 批号
Quantity enclosed 大致数量
Purchase Order number 采购订单号

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F. Packaging for shipment to Pall Europe facilities requires compliance to EU Directive94/62
relating to packaging materials and requirements.
运至 Pall 欧洲的工厂的包装要符合欧盟指令 94/62-关于包装材料的要求。
VI. Inspection 检验
Purchaser’s Quality Department will check for: 购买者的质量部门将检查如下内容：
A. Certificate of Compliance required in section V.B. VB 段中的符合性证书（COC）。
B. Proper packaging per section V.F. VF 段的包装要求。
C. Date of manufacture compared to shelf life expiration date. 生产日期和使用期限。
D. Dimensional compliance, overall appearance and visual imperfections per the standards
referenced in this specification and that reside in the Pall Inspection Method Sheets. 按照本
规范和 Pall 检查方法表中要求的尺寸符合性，整体外观和目测缺陷。
VII. Attachments 附件

Appendix A : Part Numbering (for o-ring seals only)

Appendix B : List of compounds

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Appendix A Part Numbering 附件 A 料号

OR [A] [B] – [C]
Where : Refer to table below for option codes “A” and “B”. Code “C” – O-ring sizes per AS-568 or BS1806
代号 A 和 B 参考下列表中的内容。代号 C-O 型圈的尺寸参考 AS-568 和 BS1806
“A” “B”
Pall Corporation Option Codes Defining Generic Pall Corporation Application Option Codes Ref
Description of Elastomer see notes 1 and 2 II.A for complete definition See note 3
“A”Pall 公司选择代号定义了弹性橡胶的概括性描 “B” Pall 公司的应用选择代号参考 IIA 中的完
述，见注 1 和注 2 整定义。见注 3
H Fluorocarbon elastomer E Electronics Grade
碳氟人造橡胶 电子级
HF Flurocarbon elastomer (Acid Service) L Low Durometer
碳氟人造橡胶（用于酸） 低硬度
H11 KalrezTM P Pharmaceutical Grade
制药级
H12 Chemraz® W Meet requirements of FDA and EU Regulations
for Food Contact
符合 FDA 和欧盟对食品接触的要求
H13 Nitrile rubber W1 Non-oily food contact
腈橡胶 无油食品接触
H13A Nitrile rubber for portable water usage W3 Compliant to Japanese food law
See section II.B 符合日本食品法
用于饮用水的腈橡胶，见 ILB
H26 Silastic U Use for housing seals only
硅橡胶 只用于滤壳密封
H27 Silicone elastomer for drinking water usage. - General PurposeBut qualified by Pall
See section II.B 般用途，但由 Pall 规范
用于饮用水的硅人造橡胶，见 IIB
H28 Flurocarbon elastomer, MTBE based
Refinery fluids
碳氟人造橡胶，基于流体精炼的 MTBE
H31, Platinum cured silicone elastomer
H32 铂烧结硅人造橡胶
H33 Silicone elastomer for NPL Beer Market
用于日本啤酒市场的硅人造橡胶
H4 Silicone elastomer
硅人造橡胶
J Ethylene Propylene Rubber(EPR)
乙丙橡胶
J4 Ethylene Propylene Rubber for drinking water
usage. See section II.B
用于饮用水的乙丙橡胶，见 IIB
J7 Ethylene Propylene Rubber, 375°F
Continuous steam service
乙丙橡胶，用于 375℉的连续蒸汽过滤
Notes:
1. Pall has established global option codes that describe the generic elastomer. Reference Pall International Product
Standards Database SQP#9401.
Pall 建立了概括的弹性橡胶的全球的选择代号。参考 Pall 国际产品标准数据库 SQP#9401。这数据库只供 Pall 内部使用，
如无 Pall 公司管理者的批准不能向供应商提供。
2. See Appendix “B” for specified compounds. 见附录 B 的特定的化合物。
3. It is allowable to combine multiple application codes. Locate option codes in part number in alphabetical order.
允许多项选择，料号选项代号按照字母表顺序排列。

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Appendix B -Approved Material List
附录 B-批准的材料表
Colour and 3A
Option
Compound Dairy class for Cure
Code Application Durometer
选项代 应用 Type**
化合物类别 硬度 “W” grade
颜色和 W 级产品的
System
加工体系
号 3A 奶制品级别
Brick Red (3A Bisphenol
Fluorocarbon
氟碳化合物 Class 1) 双
(Sulpher free)
砖红（ 级）
E P W 70
3A 1 酚类（不含硫
Brown 棕
Fluorocarbon Bisphenol
L
氟碳化合物 50
双酚类
Green 绿
Fluorocarbon Bisphenol
H 氟碳化合物 55
双酚类
Dark Brown 深棕
Fluorocarbon Bisphenol
P
氟碳化合物 70
双酚类
Brown 棕
Fluorocarbon Bisphenol
-
氟碳化合物 75
双酚类
Black 黑
Fluorocarbon Bisphenol
U
氟碳化合物 70
双酚类
White 白
ISO 13000-1
H2 P 55 N/A
PTFE(Virgin)
Red 红
Silicone Peroxide
E P
硅树脂 60
过氧化物
Red 红
Silicone Peroxide
E P W
硅树脂 50
过氧化物
Silicone Red (3A Class 03) Peroxide
H4 E P W
硅树脂 60
红（ 3A 03 级） 过氧化物
Orange-Red 橙红
Silicone Peroxide
L
硅树脂 50
过氧化物
Red 红
Silicone Peroxide
硅树脂 50
过氧化物
Black 黑
TPT (tetra-phenyl
tin) TPT 四苯基锡
TM
H11A E Kalrez 75

Black 黑 Proprietary 专利
TM
H11B E Kalrez 75

Black 黑 Proprietary 专利
TM
H11D P W Kalrez 70

H12 E Chemraz ® 70 Cream 奶油色 Proprietary 专利

E P Nitrile 腈 70 Black 黑 Peroxide
过氧化物
L Nitrile 腈 50 Black 黑 Sulphur 硫磺

H13 L Nitrile 腈 50 Black 黑 Peroxide

过氧化物
腈 （3A class I）
Black
Thiuram 秋兰姆
- Nitrile 75
黑（3A 1 级）
Sulphur (Donor
腈 Black (3A Class 03)
黑（ 级） System)
硫磺（原料系统）
U Nitrile 70
3A 03

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H13A U Nitrile 腈 70 Black 黑 Sulphur 硫磺

H24 E Armor Crystal 60 to 70 Transparent 透明 Proprietary
专利
H26 E Silastic 硅橡胶 71
Translucent Amber
半透明琥珀色 Proprietary 专利
H27
See Section
11.B
Silicone 硅树脂 60 Red 红
Peroxide
过氧化物
MTBE Fuel
H28 N/A
Resistant
Fluorocarbon MTBE
80 Black 黑 Bisphenol
双酚类
耐油氟碳化合物
H31 P Silicone 硅树脂 80 Clear 清晰 Platinum 铂
H32 W Silicone 硅树脂 70 Blue 蓝 Platinum 铂
UP W3 Silicone 硅树脂 70 TBD TBD

硅树脂 Rust （3A Class I） Peroxide

H33 UW Silicone 75
铁锈红（3A 1 级） 过氧化物
Rust（3A Class 03）
U Silicone 硅树脂 70
铁锈红（3A 03 级
Peroxide
过氧化物
Black 黑
Fluorocarbon Peroxide
HF E
氟碳化合物 75
过氧化物
Ethylene Propylene Black Peroxide

E P
Rubber 乙丙橡胶 75
黑 过氧化物
Ethylene Propylene Black Peroxide
Rubber 乙丙橡胶 65
黑 过氧化物
Ethylene Propylene Black (3A Class 03) Peroxide

J
E P W
乙丙橡胶 70
黑（ 3A 03 级） 过氧化物
Black 黑
Peroxide

L
EPDM 50
过氧化物
Ethylene Propylene
Rubber 乙丙橡胶 50 Black 黑 Peroxide
过氧化物
Ethylene Propylene Black (3A Class 03) Peroxide
UW
Rubber 乙丙橡胶 70
黑（ 3A 03 级） 过氧化物
Black 黑
Ethylene Propylene Peroxide
乙丙橡胶 过氧化物
See Section
J4 70
11.B

-
Ethylene Propylene
Rubber 乙丙橡胶 75 Black 黑 Peroxide
过氧化物
J7
P EPDM 70 Black 黑 Sulphur
硫磺
* Suitable for use in Europe only
** For specific Approved supplier and formulation numbers please contact pall Corporation.

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