ASTM F1313-90 (2011) PDF

Full title and description

ASTM F1313-90(2011) — Standard Specification for Volatile N‑Nitrosamine Levels in Rubber Nipples on Pacifiers. The specification sets test and acceptance provisions for quantifying volatile N‑nitrosamines released from rubber pacifier nipples and is intended to reduce normal exposure to these substances in infant products.

Abstract

This specification applies to the nitrosamine content of rubber used to manufacture nipples for infant pacifiers (does not apply to plastic nipples). It identifies a group of volatile N‑nitrosamines of concern and requires a methylene‑chloride extraction method to determine nitrosamine levels. The document establishes maximum permitted levels and uniform test procedures to assess compliance.

General information

• Status: Withdrawn (originally reapproved 2011; withdrawn January 13, 2020).
• Publication date: Published / reapproved in 2011 (ASTM F1313‑90 reapproved 2011).
• Publisher: ASTM International (Committee F15.22 — Consumer Products).
• ICS / categories: 67.250 (Toys; children’s products / juvenile products).
• Edition / version: Designation shown as ASTM F1313‑90(2011) (also referenced as F1313‑90R11 in ASTM records).
• Number of pages: 7 pages.

Scope

The specification applies specifically to volatile N‑nitrosamines present in rubber materials used for infant pacifier nipples. It establishes acceptable nitrosamine limits (and the approach to set them), gives a uniform extraction and analytical approach (methylene‑chloride extraction followed by appropriate analysis), and excludes non‑rubber (plastic) nipples. The purpose is to limit infants’ exposure to volatile N‑nitrosamines originating from rubber pacifier components.

Key topics and requirements

• Target analytes: lists of volatile N‑nitrosamines covered by the specification (examples include N‑nitrosodimethylamine, N‑nitrosodiethylamine, N‑nitrosodibutylamine, N‑nitrosomorpholine, N‑nitrosopiperidine, N‑nitrosopyrrolidine and related compounds).
• Test method: methylene‑chloride extraction procedure specified for isolation of volatile nitrosamines prior to instrumental analysis.
• Acceptance criteria: establishment of maximum allowed nitrosamine levels and procedures for reporting and evaluating results (see the standard text for numeric limits and units).
• Material scope: applies to rubber nipples only; plastic nipples explicitly excluded.
• Precautionary and safety notes: references to safety practices for laboratories and specific appendices describing hazards and test‑method precautions.

Typical use and users

Used by manufacturers of infant pacifiers and rubber components, quality assurance and testing laboratories, regulatory and compliance teams in juvenile products, product safety consultants, and independent testing bodies assessing nitrosamine content in rubber pacifier nipples. It is referenced when specifying product acceptance criteria and for pre‑market or routine batch testing.

Related standards

Other ASTM consumer‑product and toy safety standards maintained by Committee F15 (and its subcommittee F15.22) are commonly used alongside F1313 for broader juvenile product safety assessment. The F1313 entry has been succeeded by a later ASTM designation (F1313‑25) that updates and re‑establishes the specification in active form. Users should check the active F1313‑25 text for current limits and methods.

Keywords

ASTM F1313, nitrosamines, N‑nitrosamine, pacifier, rubber nipple, juvenile products, methylene chloride extraction, consumer product safety, F15.22.

FAQ

Q: What is this standard?

A: ASTM F1313‑90(2011) is a specification that defined allowable levels and test methods for volatile N‑nitrosamines in rubber nipples used on infant pacifiers.

Q: What does it cover?

A: It covers the identification of a set of volatile N‑nitrosamines of concern, a methylene‑chloride extraction test procedure, and maximum permissible levels for those substances in rubber pacifier nipples; plastic nipples are excluded. For precise analytical steps and numeric limits, consult the full standard text.

Q: Who typically uses it?

A: Manufacturers, product safety and compliance teams, and testing laboratories that evaluate rubber pacifier nipples for nitrosamine content use this specification as the basis for testing and acceptance. Regulatory and certification bodies may reference it when assessing product safety.

Q: Is it current or superseded?

A: ASTM F1313‑90(2011) was withdrawn on January 13, 2020. The topic was later reinstated and republished by ASTM as ASTM F1313‑25 (active, published 2025), which re‑establishes and updates the specification; users should rely on F1313‑25 for current requirements.

Q: Is it part of a series?

A: It is part of ASTM Committee F15's consumer‑products work (subcommittee F15.22) and sits within the broader family of ASTM standards addressing toys and juvenile product safety; the F1313 designation is the specific number for the nitrosamine specification.

Q: What are the key keywords?

A: Nitrosamines, volatile N‑nitrosamines, pacifier nipple, rubber, methylene‑chloride extraction, juvenile product safety, ASTM F1313, F15.22.